FDA recall D-1497-2022

Padagis US LLC · Class II · drug

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-08-17
Report date
2022-09-07
Termination date
2023-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2022