Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control has been informed that the Hong Kong Department of Health (DH) on 20th may 2016 suspended three batches of children’s panadol 200ml suspension meant for 5 to 12 years. The panadol which is used for relieving mild to moderate pain such as headache, migraine, nerve pain (Neuralgia), toothache, sore throat, earache, fever, pains and discomfort associated with colds and flu was recalled over traces of metals and inert fibre contamination which could render the medicine less effective as well as cause allergic reactions when consumed. This product comes in pack size of 200ml of suspension (5-12years) 48mg/ml of 2 different flavours (strawberry and orange flavour).

 

 

DETAILS OF THE RECALLED PRODUCT

 

Product name: Children’s panadol (5 to 12 years) 200ml (48mg/ml).

Product manufacturer: GlaxoSmithKline consumer health Australia.

Expiry date: February 2018

Batch number:   136418 (Strawberry flavour)

                        136444 (strawberry flavour)

                        136443 (orange flavour)

 

NAFDAC implores importers to ensure that they do not import any of the above named batches and outlets with these panadols should immediately stop sale or distribution and submit it to the nearest NAFDAC office for appropriate action.

Consumers are advised to check the bottle label and/or the base of the outer box to see if it is from batch numbers as stated above. Consumers are advised to discontinue the use of the product and return same to the place of purchase or nearest NAFDAC office for appropriate action.

 

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

The attention of the Agency has been drawn to the recent recall of one batch of Apo-Cabergoline (500MCG) by the Singapore Health Authority due to the desiccant present in the bottle cap of the drug which may not protect the product from moisture through the shelf-life thereby resulting to the reduction/degrading of the active ingredient overtime on long-term storage.

Apo-Cabergoline is a drug used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, pituitary prolactinomas (Tumours of the pituitary gland)

Details of the product:

Product name: Apo-Cabergoline 500MCG

Batch number: MK0903

Expiry date: 02/2017

Visual colour: White coloured, capsule shaped flat scored tablets.

Dosage form: Tablet

Park type: Bottle

Healthcare providers and pharmacists in possession of the above drug should take note and inform patients, also return all the unused products to the nearest NAFDAC office nationwide.

NAFDAC encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to 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 Agency is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. It is currently unknown why the reactivation occurs.

Direct-acting antiviral medicines are used to treat chronic hepatitis C virus (HCV) infection, an infection that can last a lifetime. These medicines reduce the amount of HCV in the body by preventing HCV from multiplying, and i most cases, they cure HCV. Without treatment, HCV can lead to serious liver problems cirrhosis, liver cancer, and death.

The FDA has identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. As a result, the FDA is requiring a Boxed Warning, about the risk of HBV reactivation to be added to the drug labels of these DAAs directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment. This warning will also be included in the patient information leaflet or Medication Guides for these medicines.

 

Healthcare provider’s action

 

  • Healthcare providers should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment follow-up.
  • Healthcare providers and patients should report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASOR (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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