Ultra Seal Corporation recalls North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablet…

Recall date

October 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0074-2022

FDA classification

Class III

Brand / firm

Ultra Seal Corporation

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917