Drug product
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
D-0997-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 70743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,400 unit dose cups (20 mL each)
- Official record key
drug-enforcement:D-0997-2015
Official wording
Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Code information: Lot # 624271, Exp. Date 10/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification