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Recall Observatory FDA recall evidence

Drug product

OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15

D-0442-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
75996 units
Official record key
drug-enforcement:D-0442-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22 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