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Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottl...

FDA Recall #D-0602-2022 — Class II — October 26, 2021

Recall #D-0602-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26

Reason for Recall

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

Recalling Firm

Perrigo Company PLC — Allegan, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,024 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1CK0963, Exp 12/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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