Recalls / Class II
Class IID-0054-2021
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
- Affected lot / code info
- Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Why it was recalled
SUBPOTENT DRUG
Recalling firm
- Firm
- Bausch Health Companies, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 35424 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-07-13
- FDA classified
- 2020-10-26
- Posted by FDA
- 2020-11-04
- Terminated
- 2022-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0054-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.