D-0598-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 2, 2022
- Initiation Date
- October 26, 2021
- Termination Date
- September 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,688 bottles
Product Description
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16
Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Distribution Pattern
Nationwide in the USA
Code Information
Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023