FDA-Drug2021-11-03Class III
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
Ultra Seal Corporation
Hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Sold states
Nationwide in the USA.
Affected count
250,000 tablets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief