D-0026-2015 Class III Terminated
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