Drug 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
D-0074-2022
Product summary
- Event
- Event 88843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 250,000 tablets
- Official record key
drug-enforcement:D-0074-2022
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Code information: Lot #: AK-9371, exp. date 21-Nov
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification