Drug product
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
D-0579-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,868 bottles
- Official record key
drug-enforcement:D-0579-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1AK1031, Exp 12/31/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations