India, June 5 -- 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 ha...