D-1535-2022 Class II
FDA drug recall D-1535-2022 was initiated by Direct Rx on Sep 12, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Affected quantity: 20 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 21, 2022
- Initiation Date
- Sep 12, 2022
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1535-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026