Drug product
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
D-0532-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,429,211 tablets
- Official record key
drug-enforcement:D-0532-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: L202L Bulk Lots: 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, 19H074
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations