Public Alert No. 012/2020-Presence of Suspected Falsified SA’A TRIM (Sulfamethoxazole) circulating in an illicit market in Chad
October 13, 2020,
The National Agency for Food and Drug Administration and Control has received information from WHO that a stakeholder DIFAEM has confirmed the presence of Suspected Falsified SA’A TRIM (Sulfamethoxazole) circulating in an illicit market in Chad.
The active pharmaceutical ingredients of the Genuine SA’ATRIM are a combination of two antibiotics (Sulfamethoxazole BP 400MG, Trimethoprim BP 80MG). It is used to treat a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections). It is also used to prevent and treat a type of pneumonia (pneumocystis-type).
Laboratory analysis and assay conducted on the suspected falsified SA’ATRIM on behalf of DIFAEM, concluded that the Active Pharmaceutical Ingredients (API) are below specification (16.3 and 17.6% of the declared API respectively). The product does not comply with monograph specifications with regard to dissolution, weight variation, and assay tests.
The details of the suspected Substandard product (SA’A TRIM- Sulfamethoxazole) are as follows:
|SA’A TRIM (Sulfamethoxazole)
|Stated Product Manufacturer
|SA’A Pharmaceutical Products Ltd, Kano, Nigeria
|Declared Active ingredient
|Sulfamethoxazole BP 400MG, Trimethoprim BP 80MG(16.3%/17.6%)
It should be noted that;
- 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.
- 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.
- There is no record in the NAFDAC Registered Products Database (NARPAD) of further renewal of the registration of SA’A TRIM Tablet by the Agency on expiration of its validity in 27/2013 neither is there a record of application for renewal of the registration of SA’A TRIM Tablet by SA’A Pharmaceutical Products Ltd from 2013 -date.
NAFDAC implores distributors, retailers and consumers to exercise caution and vigilance to avoid the distribution, sale and use of the affected product.
Members of the public in possession of the affected product are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via firstname.lastname@example.org or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng
NAFDAC…………..Safeguarding the health of the Nation!!!