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Recall Observatory FDA recall evidence

Drug product

Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13

D-0362-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
43008 units
Official record key
drug-enforcement:D-0362-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 19105, Exp 04/22; 19050, Exp 02/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility