Recalls & Alerts Published by NAFDAC

The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the recall of three brands of Fleming pharmaceutical products on November 14, 2016 by the Hong Kong Department of Health (DH) over misinformation of the package label instruction which do not match with the registered version, thereby rendering the products unregistered and unsafe for human consumption. The products which contained amoxicillin and clavulanic acid were supplied by Hong Kong-based Medreich Pharmaceutical franchise, Medreich Far East Limited.

THE RECALLED PRODUCT DETAILS: 

PRODUCT NAME REGISTRATION NUMBER
Fleming Tablets 1g HK- 52242
Fleming for oral suspension 457mg/5m HK- 56072
Fleming for suspension 228.5mg/5ml HK- 56069

HEALTHCARE PROVIDER’S ACTION

  • Healthcare providers and patients in possession of these affected products should stop using them.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC........Safeguarding the Health of the Nation!!!

The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the recall of three lots of Fentanyl Citrate Injection, 50mcg/mL over confirmed ampoules with broken tips.

Fentanyl is a potent, synthetic opioid pain medication with a rapid onset and short duration of action. It is a potent agonist at the μ-opioid receptors. Fentanyl Citrate Injection is indicated as short-term analgesia during anaesthetic periods, premedication, induction and maintenance and as an analgesic supplement in general or regional anaesthesia. Fentanyl Citrate is used for intravenous (IV) or intramuscular (IM) use.

PRODUCT DETAILS: 

  • NAME- Fentanyl Citrate Injection 50mcg/mL

# Affected Lot Numbers:  59277EV, 60028EV

  • EXPIRY DATES- 1st November 2017, 1st December 2017.

 

HEALTHCARE PROVIDER’S ACTION

  • Healthcare providers should provide adequate warnings to stop using the affected products.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC.........Safeguarding the Health of the Nation!!!

The National Agency for Food and Drug Administration and Control has been notified about the Essure labeling which now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Adverse event associated with the use of this product should be reported to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC………Safeguarding the health of the nation!!!

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