D-0646-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 3, 2016
- Initiation Date
- January 18, 2016
- Termination Date
- January 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119,393 Bottles
Product Description
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 Pattern
U.S. Nationwide including Puerto Rico.
Code Information
Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017.