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Recall Observatory FDA recall evidence

Drug product

CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895

D-0380-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
39,288 units
Official record key
drug-enforcement:D-0380-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility