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Recall Observatory FDA recall evidence

Drug product

Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59

D-0368-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
55772 units
Official record key
drug-enforcement:D-0368-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: KT19146 02/21 06/05/2019 KT18133 04/20 12/12/2018 KT18194 07/20 01/15/2019 KT18129 02/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility