FDA-Drug2016-02-03Class III
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), 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) 905,956 Bottles, b) 191,375 Bottles
Manufactured in
8500 Hidden River Pkwy, N/A, Tampa, FL, United States
Products
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2016Don't want to check this manually?
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