Drug product
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
D-0552-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,066,434 tablets
- Official record key
drug-enforcement:D-0552-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations