TOPIC: Sulfamethoxazole / Trimethoprim Tablets USP, 400 mg/80 mg Only by Amneal Pharmaceutical: Recall - Due to Microbial Contamination
AUDIENCE: Patient, Health Care Provider, Pharmacy, Urology, Otolaryngology, Pulmonology, Gastroenterology
ISSUE: Amneal Pharmaceutical is recalling three lots of Sulfamethoxazole/Trimethoprim tablets USP, 400 mg/80 mg because 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.
Risk Statement: 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.
The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 to 5/15/2025 only.
This recall pertains only to the 400 mg/80 mg strength. No other Sulfamethoxazole/Trimethoprim tablets USP, 400 mg/80 mg lots are impacted.
To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall.
For more information about this recall click on the red button "Read Recall" below.
BACKGROUND: The product being recalled 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.
RECOMMENDATIONS:
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Wholesalers/distributors are being asked to notify their customers of the recall and provide instructions to contact Amneal for the return of the recalled products to Amneal.
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Retailers are being asked to notify their customers and instruct consumers to contact Amneal directly for assistance with return of any recalled product and reimbursement information.
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Individuals with questions regarding this recall can contact Amneal Pharmaceuticals by phone: 833-582-0812; fax: 631-983-2595; email to: sulfamethoxazole-trimethoprim-recall@amneal.com.
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For Medical Inquiries or to report Adverse Events, or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472 or email at DrugSafety@amneal.com.
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