NAFDAC Alerts The Public Of The Circulation Of Falsified Sulfamethoxazole Drug

The National Agency for Food and Drug Administration and Control has notified the general public that it has received information from the World Health Organization that a stakeholder, DIFAEM has confirmed the presence of “Suspected Falsified SA’A TRIM “(Sulfamethoxazole) illegally circulating in Chad.

The original SA’ATRIM contains antibiotics; Sulfamethoxazole BP 400MG, and Trimethoprim BP 80MG) and it is used to treat bacterial infections like middle ear, urine, respiratory, and intestinal infections, it is also used to prevent and treat pneumocystis-type.

According to NAFDAC, laboratory test conducted on the suspected falsified SA’ATRIM on behalf of DIFAEM, reveals that the Active Pharmaceutical Ingredients are below specification and does not comply with monograph specifications with regard to dissolution, weight variation, and assay tests.

The suspected substandard product, SA’A TRIM- Sulfamethoxazole , is manufactured by SA’A Pharmaceutical Products Ltd, Kano, Nigeria, with batch number ST191097. It’s expiry date is 10/2022. It’s active ingredients are Sulfamethoxazole BP 400MG, Trimethoprim BP 80MG(16.3%/17.6%.

According to NAFDAC the genuine product is registered by NAFDAC as a branded generic, SA’A Co-trimoxazole Tablet with NRN: 04-2861 in 28/3/2002 for SA’A Pharm. Co. Ltd, Sharada Phase II, Kano. The registration was renewed in 29/2/2008 by the Agency with the brand name SA’A TRIM Tablet with NRN: 04-2861 for SA’A Pharmaceutical Products Ltd, 100 Sharada Industrial Estate, Phase II, Kano.

NAFDAC thereby charged distributors, retailers and consumers to be cautious and vigilant to avoid the distribution, sale and use of the affected product.

NAFDAC hereby urged members of the public in possession of the affected product to desist from using or selling it and submit stock to the nearest NAFDAC office.

NAFDAC has thereby asy healthcare professionals and consumers to report adverse effects or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR 20543 TOLL FREE , or through pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng.