Amneal Pharmaceutical LLC, a unit of Amneal Pharmaceuticals, Inc., is recalling three lots of Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, to the consumer level due to potential microbial contamination, according to the U.S. Food and Drug Administration.
The recall was initiated after the observance of black spots was reported in a product quality complaint.
The recalled product is used to treat UTIs, ear infections in children, bronchitis flare-ups, enteritis, and traveler's diarrhea caused by specific susceptible bacteria.
The company is warning that oral products contaminated with Aspergillus can cause serious infections, especially in immunocompromised patients.
However, no related adverse events have been reported so far.
The recall applies only to Sulfamethoxazole and Trimethoprim 400 mg/80 mg tablets in 100 and 500 count bottles from specific lots.
The impacted lot numbers are AM241019 and AM241020 in 100 count bottles and AM241019A in 500 count bottles.
Other lots of the product are not affected.
The recalled product was distributed across the United States to wholesalers and distributors between December 4, 2024, and May 15. It has an expiration date of June 2027.
Amneal is informing customers through UPS and organizing the return of recalled products.
The company has urged wholesalers and distributors to alert their customers and share return instructions. Retailers are also asked to notify consumers and direct them to contact Amneal for return assistance and reimbursement details.
In recent recalls, New York-based Ascent Consumer Products Inc. recalled one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System in February due to a confirmed test result of microbial contamination with Staphylococcus aureus.
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