D-0074-2022 Class III Terminated

Recalled by Ultra Seal Corporation — New Paltz, NY

Recall Details

Product Type
Drugs
Report Date
November 3, 2021
Initiation Date
October 13, 2021
Termination Date
March 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
250,000 tablets

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.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: AK-9371, exp. date 21-Nov