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

FDA recall notice · announced October 22, 2014 · Valeant Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot number 13052B, Exp. 03/2015, NDC16781-382-15
Quantity: 1663 tubes
Status: Terminated
Products in this recall event:
- 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 4347 (D-0025-2015)
- 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 (D-0026-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.