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Recall Observatory FDA recall evidence

Drug product

Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15

D-0463-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
41925 units
Official record key
drug-enforcement:D-0463-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17281 9/19 18120 5/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility