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Recall Observatory FDA recall evidence

Drug product

CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

D-0374-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
365,832 units
Official record key
drug-enforcement:D-0374-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17196 08/19 17192 09/19 17355 11/19 18024 01/20 18036 02/20 18237 09/20 18293 12/20 18105 04/20 18179 07/20 19040 2/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility