Drug 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)
D-0070-2022
Product summary
- Event
- Event 88843
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,484,274 tablets
- Official record key
drug-enforcement:D-0070-2022
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Code information: 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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification