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Recall Observatory FDA recall evidence

Drug product

OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01

D-0447-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
55,134 units
Official record key
drug-enforcement:D-0447-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 18026 1/21 18100 4/21 19052 2/22 19130 5/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility