Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE W...

FDA Recall #D-0593-2022 — Class II — October 26, 2021

Recall #D-0593-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26

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

3,840 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1GK0905, Exp 01/31/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated