Drug product
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
D-0094-2022
Product summary
- Event
- Event 88976
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166,920 unit dose cups
- Official record key
drug-enforcement:D-0094-2022
Official wording
Reason: cGMP Deviations: Product manufactured with contaminated raw ingredient.
Code information: Lot#: 503670
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
cGMP Deviations