PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 3, 2021 Initiated: October 13, 2021 #D-0074-2022

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
250,000 tablets
Distribution
Nationwide in the USA.
Location
New Paltz, NY

Frequently Asked Questions

What product 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. Recalled by Ultra Seal Corporation. Units affected: 250,000 tablets.
Why was this product recalled?
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 3, 2021. Severity: Low. Recall number: D-0074-2022.