FDA recall D-1535-2022

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 for recall

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

Key facts

Status

Completed

Initiation date

2022-09-12

Report date

2022-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1535-2022