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Recall Observatory FDA recall evidence

Drug product

Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

D-0366-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
469128 units
Official record key
drug-enforcement:D-0366-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17384, Exp 12/19; 17259, Exp 08/19; 19002, Exp 01/21; 19041, Exp 02/21; 18222, Exp 09/20; 18084, Exp 04/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility