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Recall Observatory FDA recall evidence

Drug product

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0382-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
45864 units
Official record key
drug-enforcement:D-0382-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: RGF, Exp 07/19; RHN, Exp 08/19; RIH, Exp 09/19; RJP, Exp 10/19; RKN, Exp 11/19; SDC Exp 04/20; SFC, Exp 06/20; SFJ, Exp 06/20; SGI, Exp 07/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility