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Recall Observatory FDA recall evidence

Drug product

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

D-0071-2022

October 13, 2021

Class III

Product summary

Firm
Ultra Seal Corporation
Event
Event 88843
Status
Terminated
Classification
Class III
Quantity
1,367,525 tablets
Official record key
drug-enforcement:D-0071-2022

Official wording

Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Code information: Lot #: AK-9455, exp. date 22-Jan; AK-1109, AK-1110, exp. date 23-Mar; K-9821, exp. date 22-Sep

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-Specification