Recalls & Alerts Published by NAFDAC

The Agency is notifying you that SentreHeart is recalling FindrWIRZ Guidewire System because the polytetrafluoroethylene (PTFE) coating may separate from the wire and potentially cause serious injuries to patients. Coating separation may be caused by issues with device design or manufacturing processes.

The FindrWIRZ Guidewire system is intended for use during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems to help position over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg or wrist. The device has a hydrophilic lubricious PTFE coating, designed to reduce friction between the device and the blood vessels.

Reasons for Recall

The company initiated the recall because the PTFE coating may separate from the wire.

Possible Associated Risks

Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause serious blood clots in the patient’s bloodstream. Both circumstances could lead to serious adverse health consequences, including embolism, stroke or death.

Recalled Product Details

A total of 98 units are affected by the recall, with lot numbers 01160568, 02160586 and 07160639-150, manufactured between January 4, 2016 and July 22, 2016 and distributed between June 1, 2016 and September 26, 2016.

Healthcare Provider’s Action

  • Identify and discontinue the use of affected products.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NARDAC 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 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!!!

Page 5 of 9

ONLINE PORTALS

napams

Contact Us from Mon - Friday: 08:00-16:00 GMT+1

Write Us:

NAFDAC Corporate Headquarters,

Plot 2032, Olusegun, Obasanjo Way,

Zone 7, Wuse, Abuja, Nigeria

 

Lagos Operation Office:

Plot 1, Industrial Estate, Lagos- Oshodi Apapa Express Way, Isolo, Lagos, Nigeria

 

 

 

 

 

 

For Enquiries:

Call: +234(0)-1-4609750

Email:nafdac@nafdac.gov.ng

 

 

 

 

 

 

 

 

 

 

 

For Complaints:

Call: +234(0)909-763-0506

         +234(0)909-763-0507

Email:reforms@nafdac.gov.ng

Or Send Us a Complaint

 

 

 

 

 

 

 

 

 

Contact Other NAFDAC Offices Nationwide