FDA recall D-0391-2022

Product

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

Reason for recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-12-06

Report date

2022-01-26

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Myers, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0391-2022