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Recall Observatory FDA recall evidence

Drug product

CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0387-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
238,968 units
Official record key
drug-enforcement:D-0387-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17223 07/19 17297 10/19 18017 01/20 18018 01/20 18065 03/21 18213 08/20 18247 10/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility