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Recall Observatory FDA recall evidence

Drug product

Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13

D-0426-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
202266 units
Official record key
drug-enforcement:D-0426-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17112 4/20 17303 10/20 18032 2/21 18072 3/21 18193 8/20 18235 9/21 18285 11/21 19004 1/22 19102 4/22 16260 9/19

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility