FDA-Drug2016-02-03Class III

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Bausch & Lomb, Inc.
Hazard

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Sold states
U.S. Nationwide including Puerto Rico.
Affected count
119,393 Bottles
Manufactured in
8500 Hidden River Pkwy, N/A, Tampa, FL, United States
Products
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2016

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