D-0074-2022 Class III Terminated
FDA drug recall D-0074-2022 was initiated by Ultra Seal Corporation on October 13, 2021 and is designated Class III. Reason for recall: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. The recall status is terminated (terminated March 28, 2022). Affected quantity: 250,000 tablets.
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