PlainRecordsFDA · Drug recall
Hydrocortisone Butyrate Cream 0.1%… and 1 more product
- Date
- Oct. 22, 2014
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Valeant Pharmaceuticals International
- Reason
- Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
- Distribution pattern
- Nationwide and Puerto Rico
2 products in this recall
Hydrocortisone Butyrate Cream 0.1%…
- 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
- Quantity
- 34,218 tubes
- Codes and lots
- Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
- Recall started
- Oct. 2, 2014
- Recall number
- D-0025-2015
Locoid (hydrocortisone butyrate 0.1%)…
- 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
- Quantity
- 1663 tubes
- Codes and lots
- Lot number 13052B, Exp. 03/2015, NDC16781-382-15
- Recall started
- Oct. 2, 2014
- Recall number
- D-0026-2015
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0025-2015, D-0026-2015. The agency record governs; check it and the company before acting.