Drug product
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
D-0054-2021
Product summary
- Event
- Event 86557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35424 units
- Official record key
drug-enforcement:D-0054-2021
Official wording
Reason: SUBPOTENT DRUG
Code information: Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
SUBPOTENT