Drug product
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
D-0537-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,772,640 tablets
- Official record key
drug-enforcement:D-0537-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations