FDAClass IISeptember 21, 2022

Triamcinolone Acetonide cream recall: CGMP Deviations

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

Why was Triamcinolone Acetonide cream recalled?

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

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: 12JY2216, Exp. 2/29/24

Product
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Recalling firm
Direct Rx
Quantity
20 tubes
Distribution
Physicians and Medical Facilities in GA and ID
Recall date
September 21, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
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