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Recall Observatory FDA recall evidence

Drug product

Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)

D-0372-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
17,613 units
Official record key
drug-enforcement:D-0372-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 17290, Exp 09/19; 19011, Exp 01/21; 18052, Exp 02/20; 18266, Exp 10/20; 18178, Exp07/20; 17385, Exp 12/19

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility