Recalls / Class III
Class IIID-0070-2022
Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
- Affected lot / code info
- Lot #: AK-9336, exp. date 21-Oct; K9406, AK-9407, exp. date 21-Dec; K-9860, exp. date 22-Oct; AK-1057, exp. date 23-Feb
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
- 2,484,274 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-0070-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.