Drug product
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
D-0546-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,983,360 tablets
- Official record key
drug-enforcement:D-0546-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations