Public Alert No: 0022/2019 – Alert on Recall of Glosunate Plus 50 Tablets Batch Number GK18010 Due to Unsatisfactory Report of Laboratory Analysis
December 4, 2019,
The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the Managing Director of Uche St. Company Limited to recall Glosunate Plus 50 (Artesunate 50mg and Amodiaquine 153mg) tablets Batch Number GK18010 manufactured by Globela Pharma Pvt, Gujarat, India up to retail level. Uche St. Company Ltd is the Marketing Authorization Holder (MAH) of Glosunate Plus 50 tablets.
The recall of Glosunate Plus 50 tablets Batch Number GK18010 is due to unsatisfactory report of laboratory analysis. The report of analysis established that the batch of the product failed assay, dissolution and related substances tests.
The details of the affected batch of the product are:
|Product Name||Glosunate Plus 50 (Artesunate 50mg and Amodiaquine
|Manufacturer||Globela Pharma Pvt, Gujarat, India|
NAFDAC has heightened surveillance in the thirty-six (36) States and the Federal Capital Territory, Abuja to prevent or stop the distribution and sale of Glosunate Plus 50 tablets Batch Number GK18010.
All distributors, wholesalers and retailers are implored to submit Glosunate Plus 50 tablets Batch Number GK18010 in their possession to the nearest NAFDAC office.
Healthcare providers and other members of the public are to contact the nearest NAFDAC office with any information on distribution and sale of Glosunate Plus 50 tablets Batch number GK18010
Consumers are advised to report adverse events related to use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via email@example.com or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng
NAFDAC……………Safeguarding the health of the Nation!!!