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Recall Observatory FDA recall evidence

Drug product

Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49

D-0364-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
557,376 units
Official record key
drug-enforcement:D-0364-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17196, Exp 07/19; 17292, Exp 09/19; 17355, Exp 11/19; 19040, Exp 02/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility