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Directorate General of Pharmaceutical Affairs And Drug Control

circular (200)2022

 

Circular (No.248)2020 regarding the shifting of Medicine Clearance & Export Section to the Air Cargo premises at Muscat International Airport with effect from 3rd January 2021

 CIRCULAR (No. 238)2020 regarding submission of online report to Department of Pharmacovigilance & Drug Information via MOH e-portal

 CIRCULAR(NO.220)2020-Clearance of medical equipment and supplies from(1.1.2021)

CIRCULAR (NO.190)2020 - New email ID for Pharmacovigilance Deptament

CIRCULAR(No.65)2020 - Emails and Phone Numbers for each Department

CIRCULAR(NO.56)2020-ONLINE PAYMENT

CIRCULAR (NO.155)2020 - Pharmacy Practice Law , Bylaws Number (113/2020)

CIRCULAR (NO.164)2020

CIRCULAR(NO.188)2020-WORKING HOURS

Pharmacovigilance and Drug information Department

- Warnings and Recalls.

CIRCULAR (NO.50) 2022 - Rabezole 20mg EC Tablets – Product Recall of all batches

CIRCULAR (NO.134) 2021 - Batch recall of Nucala Prefilled Pen (Autoinjector) - Mfr GSK

CIRCULAR (NO.123 )2021 - Voluntary recall of two batches of Saizen 8mg per ml Solution for Injection

CIRCULAR (NO.110 ) 2021 - Product Recall - OMIZ PLUS CAPSULES 20MG & 40MG

CIRCULAR (NO. 63 )2021 - Product Recall - Lorinase 5mg & 120mg Tabs - SPIMACO

CIRCULAR (NO.54 ) 2021 - Product Recall  PROTON TABLETS 20MG & 40MG

CIRCULAR (NO.25)2021- Voluntary Recall of certain pharmaceutical products by Julphar, UAE

Circular (No.22)2021- Recall of Profinal Suspension

Circular (No. 7) 2021 regarding Batch Recall of PROSTIGMIN INJECTION  SOLUTION (0.5MG/ML) 1ML Ampoules from Legacy Pharmaceutical Switzerland GmbH - B/No. 113833.

Circular (No. 236)2020 - Voluntary Recall (Class II) of Largactil 50mg/2ml Solution for Injection – B/No. A90142.

CIRCULAR (NO.133)2020 - Voluntary Recall of all batches of MINIRIN NASAL SPRAY 0.1MG/ML.

CIRCULAR (NO.126)2020 - Voluntary Recall of Certain Batches of SALONPAS-HOT PATCH

CIRCULAR (NO.116)2020 - Recall of Apo-Entecavir 0.5MG FCT by Apotex, Canada

CIRCULAR (NO.78)2020 - Registration suspension and recall of Ranitidine products

 Circular (No. 66)2020 - Recall of ShielD Hand Sanitizing Gel and First Hand Sanitizing Gel

-CIRCULAR(NO.33)2020- Recall of Propolsaft Syrup 125ml from Mfr: Martinez Nieto S.A., Spain

-CIRCULAR(NO.32)2020- Recall of Parafusiv IV 10mg/ml from Mfr Farmaceutical, Italy

-CIRCULAR(NO.14)2020- Voluntary Recall of Rantag 150mg Tab, Rantag 300mg Tab and Rantag Injection from Julphar/UAE

CIRCULAR (NO.08)2020 - Voluntary Recall of Moxal Plus Tab & Julphamox 500mg Caps by Julphar , UAE

CIRCULAR (NO.107)2019 - Voluntary recall of certain batches of Eloxatin 50mg per 10ml by Sanofi

CIRCULAR (NO.100)2019 - Voluntary Recall of Raniplex 150mg Tablet  by Remedica Ltd, Cyprus

CIRCULAR (NO.99)2019 - Voluntary Recall of Sucron (Iron Sucrose) 20mg/ml  by Baxter AG, India

CIRCULAR (NO.94)2019 - Voluntary Recall of CEFIM SUSPENSION 100MG/5ML by Oman Pharmaceutical Products

CIRCULAR (NO.93)2019 - Voluntrary Recall - Julphar Products, UAE (Premosan Syrup / Drops, Simvast 10mg Tab, Futasone Cream, Mixavit Syrup)

CIRCULAR (NO.92)2019 -Recall All Batches of Julmentin Forte 312mg/5ml & Julmentin Forte 156mg/5ml  Suspension.

CIRCULAR (NO.86)2019- Batch Recall of Epadoren 50mg per 2ml Ampoule Inj (Ranitidine)

CIRCULAR (NO.82)2019 - BATCH Recall ALKA UR SACHETS 

CIRCULAR (NO.81)2019 - BATCH Recall ORS NEW SACHETS

CIRCULAR (NO.74)2019 - Products Recall - Suspension of registration of products containing Ranitidine

CIRCULAR (NO.70)2019 -Julmentin Powder for Oral Suspension 156mg/5ml Batch no.0714

CIRCULAR (NO.67)2019 - Voluntary lot recall of BCG Vaccine 0.5mg/per ml, 20 dose with diluent

CIRCULAR (NO.51)2019 - Recall of Products , Mfr.Gulf Pharmaceutical Industries (Julphar), UAE

CIRCULAR (NO.49)2019 - Recall of Batches Nos. R10123 & P12712A of Pentasa Prolonged- Release Granules, Mfr. Ferring Pharmaceuticals, Germany

CIRCULAR (NO.47)2019 - Recall of product Paracetol IV, 100 ml, Mfr. Pharmaceutical Solutions Industry Ltd (PSI), KSA

CIRCULAR (NO.38)2019 - Recall of Batch No.HT6207 of Curam 156.25mg, 100ml Suspension , Mfr. Sandoz

CIRCULAR (NO.21)2019 -  Recall of products from Mfr: Saudi Arabian Japanese Pharmaceutical Company (SAJA),KSA

CIRCULAR (NO.20)2019- Recall of product Sedofan Syrup  , M/s. Julphar, UAE

CIRCULAR (NO.19)2019 - Recall of product Cefuzime 250mg & 500mg tablets, M/s. Julphar, UAE

CIRCULAR (NO.06)2019- Recall of Product Zordyl Mouthwash , M/s Julphar , UAE

CIRCULAR (NO.04)2019- Recall of Product Jusprin 81 mg Tablet , M/s Julphar, UAE

CIRCULAR (NO.76)2018- Recall of Paracetol 10mg per ml IV Infusion

CIRCULAR (NO.73)2018- Recall of Product Cefuzime 125mg/5ml Powder for suspension

CIRCULAR (NO.72)2018- Recall of Diffrent Batches of Histop 4mg Tablet

CIRCULAR (NO.68)2018- Recall of Product ConvaTec Intermittent Urology Catheters

CIRCULAR (NO.67)2018- Recall of  Lipomax 10mg, 20mg and 40mg FC Tabs from Saja Pharma, KSA

CIRCULAR (NO.65)2018- Recall of Products Glynase 5mg Tablets & Dialon 500mg FC Tablet

CIRCULAR (NO.59)2018- Recall Batches of Amoclan 156mg/5ml Suspension & Amoclan 312mg/5ml Suspension

CIRCULAR (NO.57)2018- Recall Batches of Daroxime 500mg Tablets.

CIRCULAR (NO.55)2018- Recall of Product Mebzol 100mg Tablet.

CIRCULAR (NO.52)2018- Recall of products that contain  Active Ingredient of Valsartan.

CIRCULAR (NO.49)2018- Recall Batch of Megamox Suspension 228mg/5ml.

CIRCULAR (NO.46)2018- Recall of Triocaine Injection Dental Cartridge manufactured by Trifarma.

CIRCULAR (NO.41)2018- Recall of Claradone Ointment - Recall of Batches, Medpharma, Sharjah 

CIRCULAR (NO.23)2018- Suspending the Registration of Lipodar Tablet.

CIRCULAR (NO.22)2018- Cancellation of Registration & Recall of Hydroxyethyl-starch (HES) solution for infusion.

 CIRCULAR (NO.12)2018-Voluntary recall of Megental Injection 80mg 2ml Amp by A. Menarini

CIRCULAR (NO.17)2018- Recall of diffrent batches of Lynparza 50mg.

CIRCULAR (NO.16)2018- Recall of some products manufactured by Boston Scientific.

CIRCULAR (NO.15)2018- Recall of some products manufactured by Coloplast.

CIRCULAR (NO.4)2018-Recall of Pedovex 75mg Tablets.

CIRCULAR (NO.2)2018-Recall of Adulterated & un-registered products.

- News and Alerts.

CIRCULAR (NO.110)2022-regarding Pregabalin

CIRCULAR (No.72)2022-SGTL2  inhibitors and the risk OF DKA 

CIRCULAR (No.71)2022-Brolucizumab:Risk of  INTRAOCULAR INFLAMMATION AND RETINAL VASCULAR OCCLUSION increased with short dosind intervals

CIRCULAR (No.70)2022-Safety update of pharmaceutical product containing ondansetron

CIRCULAR (No.69)2022-Amiadarone-Reminder of the risks and monitoring 

 CIRCULAR (NO.148)2021-Updation of data related to QPPV, QPPV Backup and LSR

 CIRCULAR (No.127)2021-Atezolizumab (Tacentriq) and other immune-stimulatoiry anti cancer drugs - risk of severe SCARs

CIRCULAR (No.112)2021 - Hydroxychloroquine

CIRCULAR (No.108)2021- MHRA update about Levothyroxine

 CIRCULAR (No. 86) 2021 - Bendamustine (Levact) - increased risk of non melanoma skin cancer and PML

 CIRCULAR (No.47)2021 - Half Yearly PV report for Second Half (Jul to Dec 2020)

 CIRCULAR (No.58)2021 - COVID 19 Vaccine AstraZeneca - EMA's report

 CIRCULAR (No.45)2021 - FDA updates about Vinca Alkaloid labeling for prepn of IV infusion bags

CIRCULAR (No. 33)2021 - FDA updates concerning Xeljanz, Xeljanz XR (tofacitinib)

CIRCULAR(NO.226)2020- PRAC recommendations on signals in respect of Fluoroquinolones for systemic and inhalation formulations

CIRCULAR(NO.222)- MHRA update about Ferric Carboxymaltose (Ferinject)

CIRCULAR (N0.197)2020 - Drug safety communication about Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

CIRCULAR (No.168)2020 - FDA Safety Alert reg. Invokana, Invokamet (Canagliflozin)

CIRCULAR (NO.149)2020- Half Yearly Report of PV (Jan-Jun 2020)

 CIRCULAR(No.144/2020)-Updation of data related to QPPV,QPPV Back up and LSR

 CIRCULAR (NO.142/2020) – EMA’s notification about authorized uses of the cancer medicine Yondelis

 

CIRCULAR (NO.141/2020 )– Azithromycin review of QT prolongation in the context of COVID 19 infection

 

CIRCULAR (NO.112)2020 - A reminder of The Risks of Chloroquine and HydroxyChloroquine

CIRCULAR (NO.88)2020-  The use of Hydorxychloroquine Plaquenil® in the context of COVID 19

CIRCULAR (NO.84)2020 - Chloroquine & HydroxyChloroquine

CIRCULAR (NO.83)2020 - Repoting of ICSR

CIRCULAR(NO.77)2020 European Medicine Agency’s recommendations to restrict use of fosfomycin antibiotics

CIRCULAR(NO.76)2020 European Medicine Agency’s notification about restrictions in use of cyproterone due to meningioma risk

CIRCULAR(NO.75)2020 European Medicine Agency’s notification that no change is needed in use of direct oral anticoagulants

CIRCULAR(NO.69)2020 -Hydroxychloroquine

Circular(No.62)2020 - Regarding Montelukast -Strengthened Boxed Warning due to restricting use for allergic rhinitis

CIRCUALR (NO.41)2020Restrictions in use of Cyproterone due to meningioma risk

CIRCULAR(NO.39)2020 Clozapine – FDA strengthens warning that untreated constipation can lead to serious bowel problems

CIRCULAR(NO.31)2020- ISoP 2020 Meeting in Muscat

CIRCULAR(NO.26)2020- European Medicines Agency's Safety Committee (PRAC) confirms four week limit for use of high -strength estradiol creams

CIRCULAR (NO.110)2019 -  FDA warning about Gabapentin or Pregabalin

CIRCULAR (NO.101)2019 - MHRA's Drug Alert in respect of Emerade 150, 300 and 500 mcg solution for Inj

CIRCULAR No. 96/2019 - EMA's recommendation that Xeljanz to be used with caution in patients at high risk of blood clots

CIRCULAR. No. 97/2019 - Lemtrada - EMA's recommendation for restriction of the use of Lemtrada

CIRCULAR (NO.83)2019 - ADR Reporting - Additional Link

CIRCULAR (NO.76)2019 - Support for The Annual of ISoP 2020 in Oman

CIRCULAR (NO.71)2019-  FDA's Drug Safety Communication on Ibrance  Kisqali and Verzenio for breast cancer.

CIRCULAR (NO.59)2019-  Drug Safety Communication about Xeljanz, Xeljanx XR (Tofacitinib)

CIRCULAR (NO.58)2019- Gilenya's Updated Restrictions

CIRCULAR (NO.55)2019 - Measures to Prevent Dosing Errors with Methotrexate

CIRCULAR (NO.54)2019 - Half yearly PV & ADR Report (Jun-Jul 2019)

CIRCULAR (NO.43)2019- Guideline for Direct Health Professional Communications(DHPCs)

CIRCULAR (NO.42)2019- List of Medical Journals 

CIRCULAR (NO.41)2019 - BENLYSTA (Blimumab)- Increased Risk of Serious Depression, Suicidal Indeation or Behaviour od Self Injury 

CIRCULAR (NO.36)2019 - Use of Multiple Sclerosis Medicine Lemtrada Restricted while EMA review is ongoing

CIRCULAR (NO.34)2019 - Dispensing of Metoclopramide Drops for Children under 1 year old

CIRCULAR (NO.33)2019 - Request to incorporate a section titled "Call for Reporting" in all educational materials

CIRCULAR (NO.28)2019 - Nomination of authorized Omani Local Safety Responsible ( LSR )

CIRCULAR (NO.23)2019

CIRCULAR (NO.22)2019 - FDA adds Boxed Warning for increased risk of death with gout medicine Uloric( Febuxostat)

CIRCULAR (NO.12)2019 - ADR, quality problem & medical errors monthly reports – January 2019

CIRCULAR (NO.10)2019 - Clinical Trials-Safety Reporting

CIRCULAR (NO.09)2019 - Half yearly PV & ADR Report (July-December 2018)

CIRCULAR (NO.80)2018 - Submission of CIOMS

CIRCULAR (NO.75)2018 - Submission of online reports

CIRCULAR (NO.70)2018

CIRCULAR (NO.69)2018

CIRCULAR (NO.58)2018

CIRCULAR (NO.53)2018

CIRCULAR (NO.47)2018

CIRCULAR (NO.45)2018

CIRCULAR (NO.44)2018

CIRCULAR (NO.43)2018

CIRCULAR (NO.31)2018

CIRCULAR (NO.19)2018

CIRCULAR (NO.18)2018 

CIRCULAR (NO.6)2018

 

Pharmacy Licensing Department

CIRCULAR(NO.240)2020 - Pharmacy working hours

CIRCULAR (NO.174)2020 - New pharmacy byelaw requirement

CIRCULAR (NO.172)2020 - UPDATE PHARMACY LOCATION

CIRCULAR (NO.138)2020 - Pharmacy working hours during lock down

CIRCULAR (NO.114)2020 - Allowing customers to enter the pharmacy  with precautionary measures

CIRCULARR (NO.92)2020 - Missing of controlled drug prescription

CIRCULAR (NO.91)2020 - Dispensing medicineS from society pharmacies

CIRCULAR(No.67)2020 - Dispensing through duty window

Circular(No.63)2020

CIRCULAR(NO.45)2020- Face Mask and Hand Sanitizers

CIRCULAR(NO.44)2020- Face Mask and Hand Sanitizers

CIRCULAR(NO 43)2020-Face Masks

CIRCULAR (NO.111)2019 -

CIRCULAR (NO.109)2019 -  List of Private Clinics Licensed to keep Medicines

CIRCULAR (NO.102)2019 - Participating in any Activities by Private Pharmaceutical Establishments

CIRCULAR (NO.85)2019 - 15th Annual Symposium on Good Pharmacy Practice

CIRCULAR (NO.78)2019 - 15th Annual Symposium on Good Pharmacy Practice

CIRCULAR (NO.77)2019 - 15th Annual Symposium on Good Pharmacy Practice

CIRCULAR (NO.65)2019 - Missing of Green Prescription from Duqum Hospital

CIRCULAR (NO.03)2019 - Recruitment of Omani Pharmacist & Assistant Pharmacist in the Private Pharmaceutical Establishments

CIRCULAR (NO.81)2018 - List of Pvt. Clinics Licensed to keep Medicines

CIRCULAR (NO.71)2018 - License for the Pharmaceutical Establishments, Pharmacist & Assistant Pharmacist

CIRCULAR (NO:26)2018 - Regarding Dispense of Antibiotics & other prescription only medicines

CIRCULAR (NO.25)2018

CIRCULAR (NO.1)2017-Controlled (non Psychotropic Drugs)

CIRCULAR (NO.60)2015-Controlled (non Psychotropic Drugs)

CIRCULAR (NO.86)2015-Controlled (non Psychotropic Drugs)

CIRCULAR (NO.41)1999 -List of Essential Drugs to be kept in Pvt.Pharmacies

 

Drug Control Department

CIRCULAR (NO.3)2018-Suspension of receiving all health products applications during March 2018.

CIRCULAR (NO.5)2018- Drug Pricing Control Policy Revision of Exchange Rates

CIRCULAR (NO.7)2018-Vaccine Qualified Private Institutions

CIRCULAR (NO.27)2018 - Guidelines for Product classification (version 1/2018)

CIRCULAR (NO.56)2018 - Suspension of receiving all health products applications during (1/10/2018-1/12/2018)

CIRCULAR (NO.61)2018 - Local Registration of Pharmacutical Companies & Products that are Centraly Rigestered (GCC-DR)

CIRCULAR (NO.85)2018 - Revised Fees For The Services Provided By MOH

CIRCULAR (NO.86)2018 - Data Matrix 2-D Barcoding

CIRCULAR (NO.87)2018 - CRC for Oral Liquid Preparations

CIRCULAR (NO.01)2019 - Expired / Spoiled Medicines 

CIRCULAR (NO.02)2019 

CIRCULAR (NO.05)2019 - e-CTD Baseline Submissions (Reformat)

CIRCULAR (NO.07)2019 - Pharmaceutical Products containing the Angiotensin 11 Receptor Blockers (ARBs)

CIRCULAR (NO.08)2019 - Re- Registration of Pharmaceutical Products

CIRCULAR (NO.39)2019 - Submission of Quarterly Statement of Controlled Drugs

CIRCULAR (NO.57)2019 - Variation Fee for Registered Pharmacuetical Products

CIRCULAR (NO.64)2019 - Pharmaceutical Products Containing Angiotensin Receptor Blockers (ARBs)

CIRCULAR (NO.79)2019 - Controlled (Non Psychotropic) Drugs

CIRCULAR (NO.95)2019 - Destruction of expired narcotic and psychotropic substances

CIRCUALR (NO.40)2020-  Drug Pricing Control Policy - Exchange Rate

CIRCUALR (NO.42)2020- Disposal of Expired / Spoiled medicines

CIRCULAR (NO.60)2020- Pharmaceutical products containing Ranitidine

CIRCULAR (NO.68)2020- Email IDs & Phone numbers of Drug Control Department

CIRCULAR (NO.125)2020 - Application form for Biowavers

CIRCULAR (NO.151)2020 - Online submission of import & export invoices for clearance

CIRCULAR (NO.56)2021-Registration and re-registration of health products

CIRCULAR (NO.02)2022 - The GCC regulations for product classification

CIRCULAR (NO.138)2022- OTC Products

Equipment and Medical Devices Control Department

CIRCULAR (NO.1)2018-Discontinuation of Absorb & Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems 

CIRCULAR (NO.24) 2019 - Acu-Chek Insight Insulin Pumps

CIRCULAR (NO.25) 2019 -Medtronic Dual Chamber Pacemakers

CIRCULAR (NO.26) 2019 - Breast Implant-Associated Anaplastic Large Cell Lymphoma

CIRCULAR (NO.27) 2019 - Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons

CIRCULAR (NO.30) 2019 - Increased Risk of Corneal haze associated with Raindrop Near Vision Inlay

CIRCULAR (NO.31) 2019 - Recall of Edwards Lifesciences’ Swan-Ganz Thermodilution Catheters

CIRCULAR (NO.44)2019 - Intraluminal staplers Manufactured by Ethicon Endo-Surgery LLC, USA

CIRCULAR (NO.45)2019 - Brainlab AG Recalls Spine & Trauma 3D Navigation Software due to Inaccurate Display

CIRCULAR (NO.46) 2019 - Creation of Database of Medical Devices & Equipments available in Oman Market

CIRCULAR (NO.52) 2019 

CIRCULAR (NO.56) 2019

CIRCULAR (NO.60) 2019 - Advisory Notice on MAGEC System

CIRCULAR (NO.61) 2019 - ElectroMist - Potential for Failed Stability Antimicrobial Effectiveness Testing

CIRCULAR (NO.62) 2019 - BeneHeart D1 Defibrilator - Monitor Manufactured  by Shenzhen Mindray, China

CIRCULAR (NO.72) 2019 - Professionals Regulatory Affairs Training (27 Sept. to 1 Oct.2019) Sponsorship for Omani Pharmacists.

CIRCULAR (NO.87) 2019

CIRCULAR (NO.88) 2019

CIRCULAR (NO.89) 2019

CIRCULAR (NO.90) 2019

CIRCULAR (NO.98) 2019 - Recall of Disinfectants - Opaster Anios & Surfasafe Premium , Mfr . Laboratoires Anios

CIRCULAR (NO.103) 2019 - USFDA's recall of Cautery Tip Cleaner

CIRCULAR (NO.104) 2019 - USFDA's recall of StemPro MSC SFM CTS Medium Culture

CIRCULAR (NO.105) 2019 - TGA's recall of Atellica IM Testosterone II 100 and 500 Test Kits

CIRCULAR (NO.106) 2019 - Swissmedic's Recall of FTD BKV Kit

CIRCULAR (NO108) 2019 - Recall of Halyard Closed Suction System for Neonates

CIRCULAR (NO 1) 2020-Olympus Recall of Duodenovideoscopes

CIRCULAR (NO 2) 2020-TGA Recall of Textured Nagor GFX

CIRCULAR (NO 3) 2020-GCC Recall of MiniMed 600

CIRCULAR (NO 4) 2020-TGA Recall of Aequalis Ascend Flex

CIRCULAR (NO 5) 2020-TGA Recall of Quadrox-iD

CIRCULAR (NO 6) 2020-NCMDR Recall Elecsys Troponin

CIRCULAR (NO 7) 2020- Creation of database for medical devices

CIRCULAR (NO 9) 2020- Recall of Surf Safe Premium

CIRCULAR (NO 10) 2020- Recall of Cloverleaf Footplates & AB & BC Distractor Bodies 1.0mm

CIRCULAR (NO 11) 2020- Recall of Contraception

CIRCULAR (NO 12) 2020- Recall of Scalpel Blades

CIRCULAR (NO 13) 2020- Recall of Legion AP Femoral Cutting Block

CIRCULAR (NO 15) 2020 -NCMDR Recall of EZ-IO Needle & Stabilizer Kit

 CIRCULAR(NO 16) 2020 - NCMDR Recall of FTD CE-IVD

CIRCULAR (NO 17) 2020- NCDMR Recall of Idylla ctNRAS-BRAF

CIRCULAR (NO 18 )2020 - NCMDR Recall of Polysorb Braided & Biosine sutures

CIRCULAR (NO 19)2020 - NCMDR Recall of Perfusor-Tubing PCA

CIRCULAR  (NO 20 )2020 - NCMDR Recall of Mini Compress, Compress device used in hip prothesis

CIRCULAR (NO 21)2020 - NCMDR Recall Nyco-Card D-Dimer-Invitro diagnostic test

CIRCULAR (NO 22) 2020 - MCMDR Recall of Twinfix

CIRCULAR (NO 23) 2020 -GHC recall of Arrow EZ-IO-Intraosseous vascular access needle sets_compressed

CIRCULAR (NO 24) 2020 - NCMDR Recall Giemsa Soln Biological Stain IVD

CIRCULAR (NO 25) 2020 - NCMDR FeNOBreath_reduce

CIRCULAR (NO 27) 2020 -Safety Alerts of Sterilizable Handle hub (Mfr: MAQUET)

CIRCULAR (NO 28) 2020 -Gulf Health Council recall of Infusion Pump  

CIRCULAR (NO 29) 2020 -TGA recall of Stellar 100 and Stellar 150 ventilators from Resmed.

CIRCULAR (NO 30) 2020  Safety communication of cybersecurity vulnerabilities

CIRCULAR(NO 34)2020

CIRCULAR(NO 35)2020

CIRCULAR(NO 36)2020

CIRCULAR(NO 37)2020

CIRCULAR(NO 46)2020- Recall of Elecsys CA 19-9-IVD Kit

CIRCULAR(NO 47)2020- Recall of Lifepak 15 Monitor/Defibrillator

CIRCULAR(NO 48)2020- Recall of Pilling Clear Advantage Disposable Aortic Punch

CIRCULAR(NO 49)2020- Recall of Arrow Epidural Catheterization Kits and Sets from Teleflex Medical

CIRCULAR(NO 50)2020- Recall of skin preparation Electrode Gel Lemon Prep, PediaPrep, Wave Prep and Cardio Prep

CIRCULAR(NO 51)2020- Recall of Epidural Catheterization Kits and Sets

CIRCULAR(NO 52)2020- Recall of In-Vitro Diagnostics – microbiological products from Siemens

CIRCULAR(NO 53)2020  -Recall of Infusion Pump-min 

CIRCULAR(NO 54)2020  -Recall of Alinity ci-series System Control Module-min

CIRCULAR(NO 55)2020  -Safety alerts of Anesthesia Systems-min

CIRCULAR (NO 56)2020 -Recall of Expression MR400-MRI Patient Monitoring System from Philips Healthcare

CIRCULAR (NO 57)2020 -Recall of Linear Array HPV (Human Papilloma Virus) Genotyping Test -IVD

CIRCULAR (NO 58)2020 -Philips IntelliVue TRx4841A and TRx4851A Telemetry Transceiver

CIRCULAR (NO 59)2020 -Recall of Pipeline Flex Embolization Device and Pipeline Flex Device with Shield Technology from Medtronic

CIRCULAR (NO 70)2020 - Recall of Alere NT-proBNP from Axis Shield Diagnostics Ltd

CIRCULAR (NO 71)2020 - Recall of Dimension Total Bilirubin (TBI) Flex reagent cartridge from Siemens Healthcare Diagnostics

CIRCULAR (NO 72)2020 - Recall of various surgical instruments for use at the central nervous system from Aesculap

CIRCULAR (NO 73)2020 - Recall of Atellica CH Reaction Cuvette Segment from Siemens Healthcare

CIRCULAR (NO 74)2020 - Recall of HeartStart MRx Monitor

CIRCULAR (NO 79) 2020 - Recall of low pressure tube, CO2 from Karl Storz GmbH

CIRCULAR (NO 80) 2020 - Safety alerts of Infusion Pump Systems (Alaris Sytem) from BD Diagnostic Systems

CIRCULAR (NO 81) 2020 -Recall of Olympic Brainz Monitor from Natus Medical Incorporated

CIRCULAR (NO 82) 2020 -Safety Alerts regarding Ambulatory Syringe Pumps from CME

Circular (No. 86)2020 regarding recall of Examination Gloves from Lotus, China.

CIRCULAR (NO.90)2020 - Synchron Systems ISE Electrolyte Reference Reagent.

CIRCULAR (NO.92)2020 - V60 Ventilators from Philips

CIRCULAR (NO.93)2020 - NCMDR recall of Linear Array HPV

CIRCULAR (NO.94)2020 - Recall of GEM microvascular coupler devices

CIRCULAR (NO.95)2020 - NCMDR alerts of electronic blood pressure monitor from Smiths Medical International Ltd

CIRCULAR (NO.96)2020 - WHO recall of in vitro diagnostics (IVDs)

CIRCULAR (NO.97)2020 - FSN of Atellica CH Reaction Cuvette Segment from Siemens Healthcare

CIRCULAR (NO.98)2020 - IMAGER II 5F angiographic catheters

CIRCULAR (NO.99)2020 - LeMaitre Over the wire Embolectomy catheter

CIRCULAR (NO.100)2020 -FSCA of Pipeline Flex Embolization Device from Medtronic

CIRCULAR (NO.101)2020 - Recall of StageOne & StageOne Select Bone Cement Spacer Molds

CIRCULAR (NO.102)2020 - Safety Alert of Rotor-Gene Q Software Version 2.3.4 from QIAGEN GmbH

CIRCULAR (NO.103)2020 - Safety Alert of Ventilators Bellavista from Vyaire Medical Inc

CIRCULAR (NO.104)2020 - FSCA OF Hemashield Gold & Hemashield Platinum Double Velour Vascular Grafts

CIRCULAR (NO.105)2020 - FSCA of Power Supply provided with Afinion 2 and Alere Afinion AS100 Analyzer IVD

CIRCULAR (NO.106)2020 - FSCA of BD PCEA Patient controlled epidural analgesia Administration sets

CIRCULAR (NO.107)2020-Recall of Total Prostate Specific Antigen

CIRCULAR (NO.108)2020-FSCA of Respirators, Air Purifying from 3M

CIRCULAR (NO.109)2020-Safety Alerts of Anaeshesia machine from Getinge

CIRCULAR (NO.110)2020-Safety Alert – Plasma Filter from Nikkiso Europe

CIRCULAR(NO.111)2020 - regarding measures recommended by EMA to avoid handling errors in the preparation and administration of leuprorelin depot medicines

CIRCULAR (NO 115)2020 - NCMDR Recall of R3 Acetabular Shells from(Mrf:Smith&Nephew inc)

CIRCULAR(NO 117)2020- Recall of safe CLINITUBES Blood Samplers from Radiometer

CIRCULAR(NO 118)2020-NCMDR  Field Safety Notice Of Peritoneal Dialysis Unit Tubing Sets From (MRF:Baxter Healthcare)

CIRCULAR (NO 130)2020 - GHC recall of Langston Dual Lumen Catheter from Vascular Solutions Inc

CIRCULAR (NO.131)2020 -NCMDR FSN of Aequalis Ascend Flex Stem Implants

CIRCULAR (NO.132)2020 -NCMDR recall of Infant Child Reduced Energy Electrodes

CIRCULAR (NO.134)2020 - FSN of Xevonta Dialyser LO & HI

CIRCULAR (NO.145)2020 - NCMDR Field Safety Corrective Actions of Portable general-purpose Fluoroscopic X-ray System from SIEMENS

CIRCULAR( No. 146)2020-GHC Recall of BodyGuard Infusion Administration Sets from CME America

CIRCULAR(NO.147)2020 - RECALL OF ISOLATION GOWN

CIRCULAR(No .148)2020 - NCMDR Recall of Transport Medium from Citotest Labware Manufacturing Co. Ltd

CIRCULAR(NO.150)2020 -NCMDR Recall of Hygenic Dental Dam Forceps

CIRCULAR( No.152/)2020 – NCMDR Recall of Intra-Aortic Balloon Catheters from Datascope Corp.

 

CIRCULAR(No.153)2020 – NCMDR Field Safety Notice of Elecsys Anti-TPO Assay from Roche Diagnostics GmbH

 

CIRCULAR(NO.156)2020-NCMDR Recall of Single holder for Oxygenator Neonatal/Pediatric from M/s. Maquet Cardiopulmonary GmbH

 

CIRCULAR(NO.157)2020-FDA recall of ClosureFast Micro Introducer Sheath Set from M/s. Argon Medical Device

 

CIRCULAR(NO.158)2020-NCMDR recall of Altera Spacer from M/s. Globus Medical Inc.

 

CIRCULAR(NO. 159)2020 - NCMDR FSN of Albumin Gen.2 and Bilirubin Total Gen.3 from Roche

 

 CIRCULAR(NO. 160)2020 - NCMDR FSN of Dimension Vista System from Siemens Healthcare

 

CIRCULAR(NO. 161)2020 - NCMDR Recall of Speedstitch Needle from Smith & Nephew

 

CIRCULAR(NO. 162)2020 - NCMDR recall of Liaison Measles from DiaSorin Inc

 

CIRCULAR(NO.163)2020 - NCMDR Recall of Embletta 128 USB cable from Natus Medical Inc

 

CIRCULAR(NO.165) 2020 - NCMDR Recall of Magenzix Compression Screw

 

CIRCULAR(NO.166) 2020 - FDA recall of Cytocell LPH533-A NUP98 Distal Probe Green

 

CIRCULAR(NO.167) 2020 - NCMDR recall of Profemur Modular Femoral Neck Long

 

CIRCULAR(NO.171)2020 - Smiths Medical Field Safety Notice of Medfusion 3500 and 4000 Syringe Pumps from M/s. Smiths Medical

 

CIRCULAR (NO.173)2020 -  Recall of Sterile XRD Gauze Swabs from Mfr: Medline International

 

CIRCULAR (NO.175)2020 -regarding Gulf Health Council recall of Glide Aortic Cannula from Edward Lifesciences.

 

 CIRCULAR (NO.176)2020-NCMDR recall of Blood Monitoring Unit BMU 40 from Maquet Cardiopulmonary GmbH

 

CIRCULAR (NO.177)2020-NCMDR recall of Hurricane RX Biliary Balloon Dilatation Catheter from Boston Scientific

 

CIRCULAR (NO.178)2020-NCMDR recall of Artis One from Siemens

 

CIRCULAR (NO.179)2020-NCMDR FSN of Sterilizable Switched Internal Defibrillator Paddles from Philips Healthcare

 

CIRCULAR (NO.180)2020- NCMDR Field Safety Notice of Revolution Apex CT Systems from GE Healthcare

 

CIRCULAR (NO.181)2020- NCMDR Recall of Genesis II Constrained Insert from Smith & Nephew Inc

 

 CIRCULAR(NO.182 ) 2020 - NCMDR Recall of Neonatal Cots from K Care Pty Ltd

 

CIRCULAR(NO.183)2020 - NCMDR Field Safety Corrective Action of COVID-19 IgG/IgM Rapid Test Cassette from Inzek International Trading BV

 

CIRCULAR(NO.184)2020 - NCMDR Field Safety Notice of Evis Exera II from Olympus

 

CIRCULAR(NO.185)2020-NCMDR Recall of Isolation Gowns from Xiantao Fushi Protective Products Co Ltd

 

 CIRCULAR(NO.186)2020-Boston Scientific Recall of Imager II Angiographic Catheters from Boston Scientific

 

CIRCULAR (NO.191)2020- Field Safety Corrective Action – SFDA recall of V60 Ventilators from Philips Healthcare

 

CIRCULAR (NO.192)2020- NCMDR Field Safety Notice of WO300 OR1 Fusion Control from Karl Storz SE & Co KG

 

CIRCULAR (NO.193)2020- NCMDR Field Safety Corrective Action of Patient Monitor from Draeger Medical System

 

CIRCULAR (NO.194)2020- SFDA recall of Neonatal and Pediatric Ventilator from Acutronic Medical Systems AG

 

CIRCULAR (NO.195)2020- NCMDR Recall of Langston Dual Lumen Catheter from Teleflex Medical

 

CIRCULAR (NO.196)2020- NCMDR Field Safety Corrective Action of BOND Enzyme Pretreatment Kits from Leica Biosystems

 

CIRCULAR (NO.198)2020- Field Safety Corrective Action recall of Elecsys CA 19-9 (Mfr: Roche Diagnostics Corp)

 

CIRCULAR (NO.199)2020- NCMDR Field Safety NJotice of Catheter Mounts from Armstrong Medical

 

CIRCULAR(NO.200)2020-NCMDR recall of Giestlich Bio-Oss Pen from Geistlich Pharma AG

 

CIRCULAR( No. 201)2020 – NCMDR Recall of ADVIA Centaur HER2 and Atellica IM HER2 from Siemens Healthcare Diagnostics GmbH

 

CIRCULAR( No. 202)2020 – NCMDR Field Safety Corrective Action of Flow Anesthesia Machines from Getinge International AB

 

 CIRCULAR( No. 203)2020 – NCMDR Recall of Sterile hypodermic / blunt needle – MEDOJECT from Chirana T. Injecta S.A.

 

CIRCULAR(NO.204)2020 - NCMDR Field Safety Corrective Action f Plastic Container for Sterilization

 

CIRCULAR(NO.205)2020 -NCMDR Field Safety Notice of Endoscopic Ultrasound Endoscopes

 

CIRCULAR(NO.206)2020 -NCMDR Recall of Zyphr Disposable Cranial Perforators

 

CIRCULAR(NO.207)2020 -NCMDR Field Safety Notic of V60 Ventilators

 

CIRCULAR(NO.208)2020 -NCMDR Recall of AMS 700 with MS Pump

 

CIRCULAR(NO.209)2020 -NCMDR Field Safety Corrective Action of Sofia SARS

 

CIRCULAR(NO. 221)2020- NCMDR Recall of ARCHITECT EBV VCA IgM Calibrator from Abbott

 

 CIRCULAR(NO.228)2020-NCMDR Field Safety Notice of Novocastra Liquid Mouse Monoclonal Antibody

 

CIRCULAR(NO.229)2020-NCMDR Recall of Hysteromat E.A.S.I. from Karl Storz Endoscopy UK Ltd

 

CIRCULAR(NO.230)2020-NCMDR Recall of Dual Chamber Implantable Defibrillator from Medtronic, USA

 

CIRCULAR(NO.231)2020-NCMDR Recall of Spinal Rod Cutter from Zimmer Biomet

 

CIRCULAR(NO.232)2020-NCMDR Recall of Trevo XR ProVue Retriever from Stryker Neurovascular

 

 CIRCULAR(NO.233)2020-NCMDR Field Safety Corrective Action of VITROS system Software Version 3.6 from Ortho-Clinical Diagnostics

 

 CIRCULAR(NO.234)2020-NCMDR Field Safety Notice of Omixon HLA Twin CE 4.2.0 from Omixon Biocomputing Lab

 

 CIRCULAR(NO.235)2020-NCMDR Field Safety Notice of Masterclave 10 and Masterclave 20 from BioMeriux Inc.

 

 CIRCULAR(No. 237)2020 - NCMDR Recall of Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducer from Cook Medical

 

CIRCULAR(NO. 239)2020 regarding NCMDR Field Safety Notice of Siemens Somatom from SIEMENS.

 

 CIRCULAR(No. 241)2020 regarding Recall of Antibiotic Impregnated Catheters from Medtronic.

 

CIRCULAR(NO.242)2020 NCMDR Recall of Medisafe Distal Duck Kit and Duck bag 

 

 CIRCULAR(NO.243)2020 NCMDR FSCA of Novatherm - Deltastream HC from Medos_compressed

 

 CIRCULAR(NO.244)2020 NCMDR FSN of EcoFit Cup Cementless - EcoFit Cup EPORE

 

 CIRCULAR(NO.245)2020 NCMDR FSN of Artis Zee - Q - Q.zen systems

 

CIRCULAR (NO.246)2020- Medical Device Clearance Service

 

 CIRCULAR(NO.247)2020- Recall of Intersurgical products containing Adult Ecolite Mask

 

CIRCULAR(NO.1)2021-NCMDR Field Safety Notice of BD Syringes and Needles from Becton Dickinson & Co.

 

CIRCULAR(NO.2)2021 NCMDR FSCA of JET Stream WorkSpace from Philips Healthcare

 

CIRCULAR(NO.3)2021 NCMDR FSN of ELISIO 17-H, 19-H & 19-M from Nipro Medical Corp

 

CIRCULAR(NO.4)2021 NCMDR Recall of Pediatric Venous Hardshell Cardiotomy Reservoir from Maquet

 

CIRCULAR(NO.5)2021 NCMDR FSC Action of Ortho BioVue System Cassette Products from Ortho Clinical Diagnostics

 

CIRCULAR(NO.6)2021 NCMDR FSN of Disposable Humidification Flask from Cook Medical

 

CIRCULAR(NO.8)2021-Recall of Isolation Gowns, Lab Coats

 

CIRCULAR(NO.9)2021-Recall of Hasson Trocar

 

CIRCULAR(NO.10)2021-Field Safety Corrective Action of Artiset HD DNL HC from Baxter Healthcare

 

CIRCULAR(NO.11)2021-NCMDR Field Safety Notice of G6 Sensors from DexCom Inc

 

CIRCULAR(NO.12)2021-NCMDR Recall of Face Mask from  Sandos Al Debajah Co

 

CIRCULAR(NO.13)2021- NCMDR Field Safety Corrective Action of AQT90 FLEX Analyzers from Radiometer Medical

 

CIRCULAR (NO.23)2021- NCMDR Field Safety Corrective Action of SELEXA bed chair from Likamed GmbH

 

CIRCULAR(No. 24)2021 - NCMDR Field Safety Notice of Prismaflex Control Unit from Baxter Healthcare

 

CIRCULAR(No. 26)2021 - NCMDR Recall of AQUACEL EXTRA from ConvaTec

 

CIRCULAR(No. 27)2021 - NCMDR Field Safety Corrective Action of X-ray interventional system INFX-8000, INFX-9000 series from Canon Inc.

 

CIRCULAR(No. 28)2021 - NCMDR Recall of ELISIO 17-H, ELISIO 19-H and ELISIO 19-M from Nipro Medical Corp

 

CIRCULAR(No.29/2021 - NCMDR Recall of Olympus Endotherapy Products from Olympus

 

CIRCULAR(No. 30)2021 - NCMDR Field Safety Notice of Subset of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy

 

CIRCULAR(NO.180)2021 - NCMDR Field Safety Corrective Action of Stem-Kit Reagents from M/s. Beckan Coulter

 

CIRCULAR(No. 184)2021 - GHC Recall of DLP Left Heart Vent Catheters from Medtronic

 

CIRCULAR(No. 185)2021 - NCMDR FSCA of Vista 120 Patient Monitor & CMS from Draeger

 

CIRCULAR(NO. 186)2021 - GHC Recall of Recirculator 8.0 Disposable Lavage Kits from Eight Medical International

 

CIRCULAR(NO.187)2021 - NCMDR FSCA of ARCHITECT from Abbott

 

CIRCULAR(NO. 188)2021 - FSN of MENTOR Breast Tissue Expanders (CPX4) from Johnson & Johnson

 

CIRCULAR(NO. 189)2021 - NCMDR FSCA of PrisMax, V2, ROW from Baxter Healthcare

 

CIRCULAR(NO. 190)2021 - NCMDR Field Safety Corrective Action of Sensis, Sensis Vibe Combo, Sensis Vibe Hemo from Siemens

 

CIRCULAR(NO.191)2021 - NCMDR Recall of API 50 CH Ref. 50300 Inc from BioMerieux c

 

CIRCULAR(NO.139)2022 - regarding Pilot registration of Medical Devices and Supplies.

 

CIRCULAR (NO.152)2022 - NCMDR Field Safety Notice of VITEK 2 System from  (mrf: BioMerieux Inc)

 

CIRCULAR (NO.153)2022 - NCMDR Recall of Absorbable Gelatin Hemostat from (mfr: Gelita Medical GmbH)

 

CIRCULAR (NO.154)2022 - NCMDR Field Safety Notice of VITROS XT 3400 Chemistry System VITROS XT 7600 Intergrated System from (mfr: Ortho-Clinical Diagnostics)

 

CIRCULAR (NO.155)2022 - NCMDR Field Safety Notice of IMMULITE 2000, IMMULITE 2000 Xpi from (mfr: Siemens Heaalthcare Diagnostics Product)

 

CIRCULAR (NO.156)2022 - NCMDR Field Safety Corrective Action of DEFIGRAD Touch7 from (mfr: Schiller AG ) (mfr: Philips Healthcare)

 

CIRCULAR (NO.157)2022 - NCMDR Recall of EEA Auto Suture Circular Stapler from (mfr: Medtronic)

 

CIRCULAR (NO.158)2022 - NCMDR Field Safety Notice of Oxygen Face Masks from (mfr: Philips Healthcare)

 

CIRCULAR (NO.140)2022 - NCMDR FSCA of Level 1 H-2 Pressure Chambers from Smiths Medical International Limited

 

CIRCULAR (NO.141)2022 - NCMDR FSCA of Heater-Cooler Unit HCU 40 from Maquet Cardiopulmonary GmbH

 

CIRCULAR (NO.127)2022 - NCMDR Field Safety Corrective Action of Peripheral stent system from (mfr:Medtronic)

 

CIRCULAR (NO.128)2022 - NCMDR Recall of CoolSculpting parallel plate applicators from (mfr: ZELTIQ Aesthetics, Inc. (ZELTIQ)Abbvie)

 

CIRCULAR (NO.129)2022 - NCMDR Recall of Microvisc 1%, Microvisc Plus 1.4%,Microvisc Phaco 2.5% from (mfr: Bohus BioTech AB)

 

CIRCULAR (NO.125)2022 - NCMDR Field Safety Corrective Action of EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) from (mfr: Boston Scientific Corporation).

 

CIRCULAR (NO.126)2022 - NCMDR Field Safety Corrective Action of ZOOM Programmers From (mfr: Boston Scientific Corporation)

 

CIRCULAR (NO.122)2022 - NCMDR Field Safety Notice of pacemaker Programmer From (mfr: Abbott)

 

CIRCULAR (NO.123)2022 - NCMDR Field Safety Corrective Action of Sensis, Sensis Vibe Combo From (mfr: Siemens)

 

CIRCULAR (NO.124)2022 - NCMDR Field Safety Notice of Aisys CS2, Avance CS2, & Avance CS2 Pro Anesthesia Systems from (mfr:GE Healthcare)

 

CIRCULAR (NO.117)2022 

 

CIRCULAR (NO.111)2022

 

CIRCULAR (NO.112)2022

 

CIRCULAR (NO.113)2022

 

CIRCULAR (NO.114)2022

 

CIRCULAR (NO.115)2022

 

CIRCULAR (NO.108)2022

 

CIRCULAR (NO.103)2022

 

CIRCULAR (NO.104)2022

 

CIRCULAR (NO.105)2022

 

CIRCULAR (NO.107)2022

 

CIRCULAR (NO.99)2022

 

CIRCULAR (NO.100)2022

 

CIRCULAR (NO.101)2022

 

CIRCULAR (NO.102)2022

 

CIRCULAR (NO.93)2022

 

CIRCULAR (NO.94)2022

 

CIRCULAR (NO.92)2022

 

CIRCULAR (NO.91)2022

 

CIRCULAR (NO.82)2022 NCMDR FSCA of VITROS Immunodiagnostic Prodcts

 

CIRCULAR (NO.81)2022 NCMDR FSCA of Original and Essential Kit Pedicle Screw Systems

 

CIRCULAR (NO.80)2022 NCMDR FSCA of AXIOM Sensis XP

 

CIRCULAR (NO.79)2022 Recall of Electrodes for Defibrillation

 

CIRCULAR (NO.78)2022 FSN of ARTIS icono biplane

CIRCULAR (NO.67)2022 NCMDR FSCA of LiquiBand FIX8 open Hernia Fixation Device from ( mrf: ADVANCED MEDICAL SOLUTIONS).

CIRCULAR(NO.63)2022 – NCMDR FSCA of MR ARTIS icono & ARTIS pheno systems from (mrf: SIEMENS).