FDA recall D-0025-2015

Valeant Pharmaceuticals International · Class III · drug

Product

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

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-10-02
Report date: 2014-10-22
Termination date: 2015-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2015