FDA-Drug2014-07-02Class II
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
Bausch & Lomb, Inc.
Hazard
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Sold states
Nationwide, Puerto Rico, Canada, and Hong Kong.
Affected count
35,253 tubes
Manufactured in
8500 Hidden River Pkwy, N/A, Tampa, FL, United States
Products
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1411-2014Don't want to check this manually?
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