D-0026-2015 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
1663 tubes

Product Description

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15

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 number 13052B, Exp. 03/2015, NDC16781-382-15