Why it was recalled
SUBPOTENT DRUG
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
Lot numbers, UPCs & expiration codes
Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0054-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 13, 2020
- FDA report date
- Nov 4, 2020
- Quantity
- 35424 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch Health Companies, Inc.
Original FDA data
Every field from FDA enforcement report D-0054-2021, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86557
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
- Postal code
- 08807-2867
- Report date
- Nov 4, 2020
- Product type
- Drugs
- Recall number
- D-0054-2021
- Classification
- Class II
- Recalling firm
- Bausch Health Companies, Inc.
- Product quantity
- 35424 units
- Termination date
- Mar 3, 2022
- Reason for recall
- SUBPOTENT DRUG
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 13, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2020