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Recall Observatory FDA recall evidence

Drug product

CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0393-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
464424 units
Official record key
drug-enforcement:D-0393-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility