FDA recall D-0389-2022

Product

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

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-0389-2022