Tropicamide Ophthalmic Solution USP recall: Labeling Error
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Why was Tropicamide Ophthalmic Solution USP recalled?
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Bausch & Lomb, Inc.
- Quantity
- 119,393 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Recall date
- February 3, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)