Medicine recalls
|
| |
| The United States: Amneal Pharmaceutical LLC issues a nationwide recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg only, due to microbial contamination |
| |
The US Food and Drug Administration (FDA) announces that Amneal Pharmaceutical LLC is recalling 3 lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg (lot number: AM241019, AM241019A, AM241020) to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint.
Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall.
The product is indicated for the treatment of urinary tract infections caused by susceptible strains of the following organisms: Escherichia Coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris; acute otitis media in pediatric patients; acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae; enteritis caused by susceptible strains of Shigella flexneri and traveler's diarrhea in adults.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Jun 5, 2025
Issued at HKT 14:15
|
| |
