FDA Drug recall D-1535-2022
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist
- FDA Drug
- Class II
- completed
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist by Direct Rx, citing CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1535-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-09-12 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | GA, ID |
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
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Identifiers
| ndc | 72189-330-80 |
|---|---|
| code_info | Lot: 12JY2216, Exp. 2/29/24 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1535-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.