Drug recall D-0581-2022

Class II Terminated reported Mar 2, 2022

Product

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97

Reason for recall

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

Lots and codes

Batch: 1BK0960, Exp 12/31/2022

Recall details

Recalling firm
Perrigo Company PLC, Allegan, MI
Quantity
4,992 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 26, 2021
Terminated
September 29, 2023

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