Home / Recalls / Valeant Pharmaceuticals International / D-0025-2015

D-0025-2015 Class III Terminated

Recalled by Valeant Pharmaceuticals International — Bridgewater, NJ

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

Other recalls by Valeant Pharmaceuticals International

  • D-0026-2015 Class III — Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manu (October 2, 2014)