Drug product
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
D-1080-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 82510
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,796 bottles
- Official record key
drug-enforcement:D-1080-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Code information: Lot#: 356527, Exp 3/19
Distribution pattern: AR and MS
Derived failure modes
-
Potency or specification failure
Out of Specification