Multi-event October 2014 FDA Recall Drug by Valeant Pharmaceuticals International
This Multi-event Class III drug recall was voluntarily initiated by Valeant Pharmaceuticals International on October 2, 2014 for the product Drug. The FDA reported the reason for recall as subpotent drug; for the active, hcb, and preservatives, propylparaben and butylparaben at the 18 month stability test point. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0026-2015
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
10-02-2014
10-22-2014
1663 tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Valeant Pharmaceuticals International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
04-03-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot number 13052B, Exp. 03/2015, NDC16781-382-15
Recall Number: D-0025-2015
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
10-02-2014
10-22-2014
34,218 tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Valeant Pharmaceuticals International
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
04-03-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
