Public Alert No. 0037/2018 – Recall Of Amlodipine 5mg And 10mg Tablets Manufactured By Ecomed Pharma Ltd Due To False Labelling

The National Agency for Food and Drug Administration and Control has directed Ecomed Pharma Ltd to recall three batches of Amlodipine 5mg tablets and seven batches of Amlodipine 10mg tablets due to false and misleading labelling. The company is to recall the affected batches of the product from the distributors, wholesalers and retailers.

The falsely labelled Amlodipine tablets has the inscription ‘TEVA’ on the package. Amlodipine tablets manufactured by the company that was registered by the Agency has no such inscription.

The details of the falsely labelled product are:

Product Name: Amlodipine 5mg and 10mg tablets

Product Manufacturer: Ecomed Pharma Ltd.

                                      Plot 32, Lynson Chemical Avenue, Km 38, Lagos-Abeokuta

                                      Expressway, Sango-Ota, Ogun State.

Product Name Batch Numbers Manufacturing

 Date

Expiration

 Date

NRN
 

AMLODIPINE 5mg Tablets

 

7J006001

8A006001

8A006002

 

11/2017

01/2018

01/2018

 

10/2019

12/2020

12/2020

 

A11-0395

 

AMLODIPINE 10mg Tablets

 

7L007001

7M007002

8B007001

8B007002

8E007004

8F007005

8F007006

 

11/2017

12/2017

02/2018

02/2018

05/2018

06/2018

06/2018

 

10/2019

11/2019

01/2021

01/2021

04/2021

05/2021

05/2021

 

A11-0396

Amlodipine tablet is a prescription  medicine used to treat high blood pressure, coronary artery disease, and angina (chest pain).

NAFDAC implores distributors, wholesalers and retailers to immediately stop the distribution and sale of the affected products. They should return the stock of the product in their possession to Ecomed Pharma Ltd, Plot 32, Lynson Chemical Avenue, Km 38, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State.

Consumers are advised to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC………….Safeguarding the health of the Nation!!!