D-0025-2015 Class III Terminated
FDA drug recall D-0025-2015 was initiated by Valeant Pharmaceuticals International on October 2, 2014 and is designated Class III. Reason for recall: Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point The recall status is terminated (terminated April 3, 2015). Affected quantity: 34,218 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- October 22, 2014
- Initiation Date
- October 2, 2014
- Termination Date
- April 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,218 tubes
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
Reason for Recall
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15