Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Product description
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Lot numbers, UPCs & expiration codes
Lot #: K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun
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-0076-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2021
- FDA report date
- Nov 3, 2021
- Quantity
- 42,394,018 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra Seal Corporation
Original FDA data
Every field from FDA enforcement report D-0076-2022, 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 #: K-9335, AK-9419, exp. date 21-Oct; AK-9369, exp. date 21- Nov; AK-9403, exp. date 21-Dec; AK-9452, K-9455, 9455, exp. date 22-Jan; AK-9586, exp. date 22-Feb; AK-9525, AK-9526, AK-9639, exp. date 22-Mar; AK-9568, AK-9569, AK-9567, AK-9692, exp. date 22-Apr; AK-9615, exp. date 22-May; AK-9666, exp. date 22-Jun; AK-9714, K-9714, AK-9718, K-9718, 9718, exp. date 22-Jul, AK-9719, exp. date 22-Jul; AK-9771, AK-9765, AK-9769, exp. date 22-Aug; AK-9822, AK-9818, exp. date 22-Sep; AK-9860, exp. date 22-Oct; AK-9957, exp. date 22-Dec; AK-1011, K-1014, 1014, AK-9489, exp. date 23-Jan; 1055, K-1057, 1057, AK-1058, exp. date 23-Feb; AK-1108, AK-1113, K-1199, AK-1199, exp. date 23-May; AK-1240, 1240, exp. date 23-Jun; AK-9335, exp. date 10/21; AK-9406, exp. date 21-Dec; AK-1278, exp. date 23-Jul; K-1240, exp. date 23-Jun
- Postal code
- 12561-1609
- Report date
- Nov 3, 2021
- Product type
- Drugs
- Recall number
- D-0076-2022
- Classification
- Class III
- Recalling firm
- Ultra Seal Corporation
- Product quantity
- 42,394,018 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
- Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, 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