Recalls / Class III
Class IIID-1512-2020
Product
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
- Affected lot / code info
- Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
Why it was recalled
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 4,666,355 packets
- Distribution pattern
- Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Timeline
- Recall initiated
- 2020-08-03
- FDA classified
- 2020-08-20
- Posted by FDA
- 2020-08-26
- Terminated
- 2021-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1512-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.