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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 THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16

D-0596-2022

October 26, 2021

Class II

Product summary

Firm
Perrigo Company PLC
Event
Event 88905
Status
Terminated
Classification
Class II
Quantity
5,184 bottles
Official record key
drug-enforcement:D-0596-2022

Official wording

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

Code information: Batch: 1CK1274, 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