PlainRecalls
FDA Drug Moderate Class II Completed

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.

Reported: September 21, 2022 Initiated: September 12, 2022 #D-1535-2022

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Direct Rx
Units Affected
20 tubes
Distribution
Physicians and Medical Facilities in GA and ID
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Direct Rx. Units affected: 20 tubes.
Why was this product recalled?
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 21, 2022. Severity: Moderate. Recall number: D-1535-2022.