Direct Rx: Drug Recall

Recall #D-1535-2022 · 09/12/2022

Class II: Risk

Recall Details

Recall Number
D-1535-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Direct Rx
Status
Completed
Date Initiated
09/12/2022
Location
Dawsonville, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 tubes

Reason for Recall

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

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.

Distribution Pattern

Physicians and Medical Facilities in GA and ID

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.