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Recall Observatory FDA recall evidence

Drug product

Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603

D-0322-2020

October 01, 2019

Class III

Product summary

Firm
Sato Pharmaceutical Inc.
Event
Event 83964
Status
Terminated
Classification
Class III
Quantity
21,864 units
Official record key
drug-enforcement:D-0322-2020

Official wording

Reason: Subpotent Drug

Code information: Lot #: TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 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