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Recall Observatory FDA recall evidence

Drug product

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0377-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
101,712 units
Official record key
drug-enforcement:D-0377-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility