Recall: D-1535-2022

Class II - Potentially Harmful

Class IIClassification

2022-09-12Initiated

CompletedStatus

Direct RxFirm

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.

Reason

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

Distribution

Physicians and Medical Facilities in GA and ID

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.