Drug product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
D-0995-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 70743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27,648 bottles (16 fl. oz. each)
- Official record key
drug-enforcement:D-0995-2015
Official wording
Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Code information: Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification