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Recall Observatory FDA recall evidence

Drug product

Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946

D-0325-2020

October 01, 2019

Class III

Product summary

Firm
Sato Pharmaceutical Inc.
Event
Event 83964
Status
Terminated
Classification
Class III
Quantity
39,504 units
Official record key
drug-enforcement:D-0325-2020

Official wording

Reason: Subpotent Drug

Code information: Lot #: AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, AXCK, Exp. Date Nov 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