Recall: D-1497-2022

Class II - Potentially Harmful

Class IIClassification

2022-08-17Initiated

TerminatedStatus

Padagis US LLCFirm

Product

Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.

Reason

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

Distribution

Nationwide in the USA

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