D-1535-2022 Class II

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
September 21, 2022
Initiation Date
September 12, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 tubes

Product Description

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 Pattern

Physicians and Medical Facilities in GA and ID

Code Information

Lot: 12JY2216, Exp. 2/29/24