Drug product
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26
D-0580-2022
Product summary
- Event
- Event 88905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117552 bottles
- Official record key
drug-enforcement:D-0580-2022
Official wording
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Code information: Batch: 1BK0784, Exp 12/31/2022; 1CK0997, 1CK1083, Exp 01/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations