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Recall Observatory FDA recall evidence

Drug product

CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0404-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
48,168 units
Official record key
drug-enforcement:D-0404-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17285 09/19 18067 03/20 18205 08/20 18067 3/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility