PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 7, 2022 Initiated: August 17, 2022 #D-1497-2022

Product Description

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 for Recall

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

Details

Recalling Firm
Padagis US LLC
Units Affected
57,816 tubes
Distribution
Nationwide in the USA
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Padagis US LLC. Units affected: 57,816 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 7, 2022. Severity: Moderate. Recall number: D-1497-2022.