FDAFDA · Food and drugs·Recall number D-0070-2022
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)
Published November 3, 2021 · Recall initiated: October 13, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultra Seal Corporation
- Distributor
- Nationwide in the USA.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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