D-1513-2020 Class III Terminated
FDA drug recall D-1513-2020 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: 701,735 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
- 701,735 packets
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,
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 #: 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