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

FDA Recall #D-0599-2022 — Class II — October 26, 2021

Recall #D-0599-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26

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

83760 packs

Distribution

Nationwide in the USA

Code Information

Batch: 1BK0794, Exp 12/31/2022, 1BK1035, Exp 01/31/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated