FDAFDA · Food and drugs·Recall number D-0997-2015
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Published May 20, 2015 · Recall initiated: March 17, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # 624271, Exp. Date 10/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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