Recalls / Class III
Class IIID-0074-2022
Product
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
- Affected lot / code info
- Lot #: AK-9371, exp. date 21-Nov
Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 250,000 tablets
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2021-10-13
- FDA classified
- 2021-10-26
- Posted by FDA
- 2021-11-03
- Terminated
- 2022-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0074-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.