Drug product
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
D-1339-2020
Product summary
- Event
- Event 85833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,931 tubes
- Official record key
drug-enforcement:D-1339-2020
Official wording
Reason: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Code information: Lot: Y0378, EXP 07/2021
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent