Drug recall D-0646-2016
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.
Lots and codes
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.
Recall details
- Recalling firm
- Bausch & Lomb, Inc., Tampa, FL
- Quantity
- 119,393 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2016
- Terminated
- January 6, 2020
Related products
- Tropicamide – drug information
- NDC 24208-585 Tropicamide · Tropicamide 10 mg/mL · Bausch & Lomb Incorporated
- NDC 24208-590 Tropicamide · Tropicamide 5 mg/mL · Bausch & Lomb Incorporated