The Recall Desk
ModerateFDA (Drugs)·D-0025-2015·Announced 2014-10-22

Valeant Recalls Subpotent Hydrocortisone Butyrate Cream 0.1% Tubes

Valeant Pharmaceuticals is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1% because the product failed stability testing for potency and preservative levels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a subpotent drug failure at a stability test point without reported injuries.

Plain-English summary

Valeant Pharmaceuticals International is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm, prescription only. The product is manufactured for Rouses Point Pharmaceuticals, LLC by Ferndale Laboratories, Inc. The recall covers lot numbers 13052C (expiration 03/2015) and 13156A (expiration 08/2015), identified by NDC 43478-270-15.

The recall was initiated because the drug failed to meet specifications for the active ingredient (Hydrocortisone Butyrate) and the preservatives Propylparaben and Butylparaben at the 18-month stability test point. This is classified as a subpotent drug issue.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement.

The recalled product

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
Manufacturer
Valeant Pharmaceuticals International
Category
Drug — Topical Steroid
Hazard
Affected units
34,218

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot numbers 13052C
  • exp 03/2015 and 13156A
  • exp 08/2015
  • NDC 43478-270-15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Valeant Pharmaceuticals International under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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