Drug product
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
D-0529-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 451,123 tablets
- Official record key
drug-enforcement:D-0529-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: C135LA Bulk Lots: 19F077
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations