Drug product
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotion 3 FL OZ SKU 2096469 Purell Hand Sanitizer Original 6.5 FL OZ SKU 2095985 Purell Hand Sanitizer Soothing Aloe 6.5 Fluid Ounces SKU 2095986 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
D-1363-2022
Product summary
- Event
- Event 90566
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1363-2022
Official wording
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Code information: SKUs: 998890; 999330; 2006819; 2007723; 2096469; 2095985; 2095986
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations