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Recall Observatory FDA recall evidence

Drug product

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887

D-0375-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
100,680 units
Official record key
drug-enforcement:D-0375-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17222 07/19 17386 12/19 19018 01/21 18016 01/20 18181 07/20 18104 04/20 19018 1/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility