Drug 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
D-1512-2020
Product summary
- Event
- Event 86264
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,666,355 packets
- Official record key
drug-enforcement:D-1512-2020
Official wording
Reason: Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Code information: Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
Distribution pattern: Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Derived failure modes
-
Potency or specification failure
Out-of-Specification