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Recall Observatory FDA recall evidence

Drug product

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

D-0598-2022

October 26, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88905
Status
Terminated
Classification
Class II
Quantity
68,688 bottles
Official record key
drug-enforcement:D-0598-2022

Official wording

Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Code information: Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations