FDA-Drug2016-02-03Class III
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
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
a) 416,441 Bottles b) 674,177 Bottles
Manufactured in
8500 Hidden River Pkwy, N/A, Tampa, FL, United States
Products
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2016Don't want to check this manually?
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