FDA recall D-0075-2022

Product

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Reason for recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2021-10-13

Report date

2021-11-03

Termination date

2022-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2022