D-0054-2021 Class II Terminated
FDA drug recall D-0054-2021 was initiated by Bausch Health Companies, Inc. on Jul 13, 2020 and is designated Class II. Reason for recall: SUBPOTENT DRUG The recall status is terminated (terminated Mar 3, 2022). Affected quantity: 35424 units.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 4, 2020
- Initiation Date
- Jul 13, 2020
- Termination Date
- Mar 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35424 units
Product description
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
Reason for recall
SUBPOTENT DRUG
Distribution pattern
Nationwide within the United States
Code information
Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0054-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026