D-1512-2020 Class III Terminated
FDA drug recall D-1512-2020 was initiated by Ultra Seal Corporation on August 3, 2020 and is designated Class III. Reason for recall: Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. The recall status is terminated (terminated March 16, 2021). Affected quantity: 4,666,355 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2020
- Initiation Date
- August 3, 2020
- Termination Date
- March 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,666,355 packets
Product Description
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
Reason for Recall
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Distribution Pattern
Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Code Information
Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022