Why it was recalled
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Product description
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
Lot numbers, UPCs & expiration codes
Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
Where it was sold
Nationwide and Puerto Rico
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-0025-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 2, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 34,218 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals International
Original FDA data
Every field from FDA enforcement report D-0025-2015, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69359
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
- Postal code
- 08807-2867
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0025-2015
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals International
- Product quantity
- 34,218 tubes
- Termination date
- Apr 3, 2015
- Reason for recall
- Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 2, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2014