Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160...
FDA Recall #D-0600-2022 — Class II — October 26, 2021
Product Description
Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9
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
561 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1EV1874, Exp 11/02/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated