Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Product description
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)
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0070-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 2,484,274 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra Seal Corporation
Original FDA data
Every field from FDA enforcement report D-0070-2022, exactly as published.
Show all FDA fields
- City
- New Paltz
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 88843
- Address
- 521 Main St
- 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
- Postal code
- 12561-1609
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0070-2022
- Classification
- Class III
- Recalling firm
- Ultra Seal Corporation
- Product quantity
- 2,484,274 tablets
- Termination date
- Mar 28, 2022
- Reason for recall
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Oct 13, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2021