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Recall Observatory FDA recall evidence

Drug product

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,

D-1513-2020

August 03, 2020

Class III

Product summary

Firm
Ultra Seal Corporation
Event
Event 86264
Status
Terminated
Classification
Class III
Quantity
701,735 packets
Official record key
drug-enforcement:D-1513-2020

Official wording

Reason: Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

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

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

    reason.potency_specification_failure · v1.0.0

    Out-of-Specification