FDA recall D-0646-2016

Bausch & Lomb, Inc. · Class III · drug

Product

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

Reason for recall

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

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status
Terminated
Initiation date
2016-01-18
Report date
2016-02-03
Termination date
2020-01-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tampa, FL, United States

Primary source

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