FDAFDA · Food and drugs·Recall number D-0646-2016
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Published February 3, 2016 · Recall initiated: January 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TROPICAMIDE
- Manufacturer
- Bausch & Lomb, Inc.
- Distributor
- U.S. Nationwide including Puerto Rico.
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States