Drug product
ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT MUSCLE RUB 1.25 OZ SKU 920205 ICY HOT NO MESS 1.5 OZ SKU 998751 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1435-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1435-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 901452; 911030; 920205; 998751
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations