Recalls & Alerts Published by NAFDAC

The attention of the agency has been drawn to the recall of Heartware Ventricular Assist Device Pump (HVAD) by the Heartware Incorporate due to a design problem with the Driveline connector. The Driveline connector is a tube that connects the HVAD’s pump to the external controller and power source. The HVAD pump helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and those waiting for a heart transplant.

Reason for recall:

Contamination of the driveline may result in fluid or other materials entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences including Death.

This recall affects all HVADs with serial numbers lower than HW25838, product codes 1103 and 1104, manufacturing dates are from March 17, 2006 to June 27, 2016, it has 105 units.

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 attention of the Agency has been drawn to the recent recall of all lots Megajex Natural sex Enhancer capsules by MS Bionic as a result of undeclared drug ingredients (i.e. ingredients not specified on the label). This product listed above contains Tadalafil and Sildenafil which are the active ingredients for Cialis and Viagra respectively, Tadalafil and Sildenafil are approved drugs used as treatment for male Erectile Dysfunction (ED).ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Megajex Natural Male Sex Enhancer is marketed as a dietary supplement for erectile dysfunction. It is packaged in 20 count bottles and sold nationwide.

Use of this product may pose a threat to consumers because the undeclared active ingredients may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

INFORMATION ON PRODUCTS DETAIL

  • Manufacturer: MS Bionic Incorporated.
  • Drug specification: 20 count bottles.

In view of this, the:

  • Patients taking these drugs should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.
  • Healthcare professionals are implored to report adverse effect 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!!!

Tuesday, 17 January 2017 13:43

Voluntary Recall Of 2 Batches Of Coversyl

The attention of the Agency has been drawn to the voluntary recall of 2 batches of 10mg Coversyl distributed in Nigeria from Egypt by Servier Egypt Industries. Coversyl is used to reduce blood pressure and also to treat heart failure. The batches in question were found to have brownish stains on the tablets which after analysis by Servier Laboratories showed microbial contamination which was associated with a decrease in drug substance content and high level of impurities suggesting probable improper storing, deliberate adulteration and/ or reused/ recycled tablets introduced in genuine packaging after release into the Nigerian market.

Details of Recalled Products are:

Name of Drug: Coversyl 10mg, box of 30 tablets

Batch Number: 20171

Expiry date: 10/2016

Quantity involved: 9 packs

Manufacturing site: Servier Egypt industries

Name of Drug: Coversyl 10mg, box f 30 tablets

Batch Number: 20791

Expiry date: 03/2017

Quantity involved: 8 packs

Manufacturing site: Servier Egypt industries

Healthcare professionals especially pharmacists are advised to discontinue administration of these batches to avoid risks to the patients. Patients who take this medication are advised to avoid these batches and report any adverse events 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 4 of 8

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