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Recall Observatory FDA recall evidence

Drug product

OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77

D-0482-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0482-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 18008 1/20 19105 4/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility