FDAClass IIIAugust 21, 2013

Clobetasol Propionate Cream recall: Labeling Error

Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC…

Why was Clobetasol Propionate Cream recalled?

Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP

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?

Batch/Lot 619442, exp. 01/2015

Product
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC…
Recalling firm
Hi-Tech Pharmacal Co., Inc.
Quantity
58,812 tubes
Distribution
Nationwide and Puerto Rico
Recall date
August 21, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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