FDA recall D-0600-2022

Perrigo Company PLC · Class II · drug

Product

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-10-26
Report date
2022-03-02
Termination date
2023-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0600-2022