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Recall Observatory FDA recall evidence

Drug product

CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

D-0406-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
39,072 units
Official record key
drug-enforcement:D-0406-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: RHD 08/19 RIF 09/19 RIN 09/19 RKP 11/19 SAR 01/20 SCG 03/20 SED 5/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility