Drug product
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
D-0530-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,349,148 tablets
- Official record key
drug-enforcement:D-0530-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: C140L Bulk Lots: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations