Drug product
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
D-0528-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,566,510 tablets
- Official record key
drug-enforcement:D-0528-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations