Why it was recalled
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Product description
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Lot numbers, UPCs & expiration codes
Lot #: K-8909, AK8909, Exp. Date 12/2020; AK9507, Exp. Date 03/2021; AK9072, Exp. Date 04/2021; AK9102, AK9601, AK9679, Exp. Date 05/2021; AK9145, K9145, Exp. Date 06/2021; AK9743, AK9830, Exp. Date 07/2021; AK9276, Exp. Date 09/2021; AK9391, A9392, Exp. Date 12/2021; AK9505, Exp. Date 02/2022; AK9508, AK9509 Exp. Date 04/2022
Where it was sold
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
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-1513-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2020
- FDA report date
- Aug 26, 2020
- Quantity
- 701,735 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra Seal Corporation
Original FDA data
Every field from FDA enforcement report D-1513-2020, exactly as published.
Show all FDA fields
- City
- New Paltz
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 86264
- Address
- 521 Main St
- Code information
- Lot #: K-8909, AK8909, Exp. Date 12/2020; AK9507, Exp. Date 03/2021; AK9072, Exp. Date 04/2021; AK9102, AK9601, AK9679, Exp. Date 05/2021; AK9145, K9145, Exp. Date 06/2021; AK9743, AK9830, Exp. Date 07/2021; AK9276, Exp. Date 09/2021; AK9391, A9392, Exp. Date 12/2021; AK9505, Exp. Date 02/2022; AK9508, AK9509 Exp. Date 04/2022
- Postal code
- 12561-1609
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1513-2020
- Classification
- Class III
- Recalling firm
- Ultra Seal Corporation
- Product quantity
- 701,735 packets
- Termination date
- Mar 16, 2021
- Reason for recall
- Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
- Distribution pattern
- Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
- Recall initiation date
- Aug 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2020