Recall: D-0646-2016

Class III - Minor Violations

Class IIIClassification

2016-01-18Initiated

TerminatedStatus

Bausch & Lomb, Inc.Firm

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

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

Distribution

U.S. Nationwide including Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.