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Recall Observatory FDA recall evidence

Drug product

OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59

D-0448-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
296,314 units
Official record key
drug-enforcement:D-0448-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility