Recall: D-0647-2016

Class III - Minor Violations

Class IIIClassification

2016-01-18Initiated

TerminatedStatus

Bausch & Lomb, Inc.Firm

Product

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

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.