Public Alert No: 0021/2019 – Alert on Recall of Solartep Tablets Batch Number F17S0826 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 Solutions Pharmaceutical Nigeria Limited to recall Solartep (Dihydroartemisinin 40mg/Piperaquine Phosphate 320mg) tablets Batch Number F17S0826 manufactured by Mingshen Pharmaceutical Factory, China up to retail level. Solutions Pharmaceutical Limited is the Marketing Authorization Holder (MAH) of the product.
The recall of the batch of the product is due to unsatisfactory report of laboratory analysis. The report of analysis established that Solartep tablets Batch number F17S0826 failed assay and dissolutions tests.
The details of the affected batch of the products are:
|Product Name||Solartep (Dihydroartemisinin 40mg/Piperaquine Phosphate 320mg) tablets.|
|Manufacturer||Mingshen Pharmaceuticals Factory, China|
NAFDAC has strengthened surveillance in the thirty-six (36) States and the Federal Capital Territory, Abuja to prevent or stop the distribution and sale of Solartep tablets Batch number F17S0826.
All distributors, wholesalers and retailers are implored to submit Solartep tablets Batch number F17S0826 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 Solartep tablets Batch Number F17S0826.
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 firstname.lastname@example.org or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng
NAFDAC……………Safeguarding the health of the Nation!!!