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Recall Observatory FDA recall evidence

Drug product

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

D-0584-2022

October 26, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88905
Status
Terminated
Classification
Class II
Quantity
22,140 bottles
Official record key
drug-enforcement:D-0584-2022

Official wording

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

Code information: Batch: 1CK0907, Exp 01/31/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations