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!!!
