Recall archive / FDA drug enforcement
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 3053... — FDA record D-1535-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 12, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Direct Rx
- Quantity
- 20 tubes
- Agency-reported status
- Completed
- Source record identifier
- D-1535-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 12JY2216, Exp. 2/29/24 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Physicians and Medical Facilities in GA and ID
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Sep 12, 2022
- Center classification date
- Sep 15, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.