Drug product
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
D-0536-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,249,082 tablets
- Official record key
drug-enforcement:D-0536-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations