FDA-Drug2019-11-27Class II

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

Altaire Pharmaceuticals, Inc.
Hazard

Lack of Assurance of Sterility

Sold states
U.S.A. Nationwide
Affected count
13626 units
Manufactured in
311 W Ln, PO Box 849, Aquebogue, NY, United States
Products
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2020

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