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Recall Observatory FDA recall evidence

Drug product

CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0385-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0385-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: SAS 1/21 SIA 9/21 SFE 6/21 SAS 1/21 SFE 6/21 SIA 9/21 RIE 9/20 REH 5/20 RAD 1/20 TAH 1/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility