FDA-Drug2019-11-27Class II

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

Altaire Pharmaceuticals, Inc.
Hazard

Lack of Assurance of Sterility

Sold states
U.S.A. Nationwide
Affected count
427,280 units
Manufactured in
311 W Ln, PO Box 849, Aquebogue, NY, United States
Products
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0449-2020

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