FDA-Drug2019-11-27Class II

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, 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
19632 units
Manufactured in
311 W Ln, PO Box 849, Aquebogue, NY, United States
Products
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2020

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