FDAFDA · Food and drugs·Recall number D-0025-2015
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
Published October 22, 2014 · Recall initiated: October 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valeant Pharmaceuticals International
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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