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Recall Observatory FDA recall evidence

Drug product

Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707

D-0459-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
73,548 units
Official record key
drug-enforcement:D-0459-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17131 5/20 18031 1/21 19065 3/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility