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Recall Observatory FDA recall evidence

Drug product

Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535

D-0323-2020

October 01, 2019

Class III

Product summary

Firm
Sato Pharmaceutical Inc.
Event
Event 83964
Status
Terminated
Classification
Class III
Quantity
210,744 units
Official record key
drug-enforcement:D-0323-2020

Official wording

Reason: Subpotent Drug

Code information: Lot #: TXWP, TXTP, Exp. date Jul 2020; AXTZ, Exp. date Mar 2021; AXNP, Exp. date Jul 2021; AXBC, Exp. date Oct 2021; ZXWW, Exp. date Dec 2021

Distribution pattern: Nationwide within the United States, Guam and Saipan

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent