Drug product
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
D-0696-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 76831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55,968 bottles
- Official record key
drug-enforcement:D-0696-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot# 348913, Exp.01/18; Lot# 349552, Exp.03/18; Lot# 349681, Exp. 03/18; Lot# 349683, Exp. 03/18; Lot# 349685, Exp. 03/18; Lot# 349687, Exp. 03/18; Lot# 349689, Exp. 03/18; Lot# 350636, Exp.03/18
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications