FDAClass IIIOctober 22, 2014

Hydrocortisone Butyrate Cream 0.1% recall: Subpotent

Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale…

Why was Hydrocortisone Butyrate Cream 0.1% recalled?

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale…
Recalling firm
Valeant Pharmaceuticals International
Quantity
34,218 tubes
Distribution
Nationwide and Puerto Rico
Recall date
October 22, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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