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.
Reported: February 3, 2016 Initiated: January 18, 2016 #D-0647-2016
Product Description
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 for Recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Details
- Recalling Firm
- Bausch & Lomb, Inc.
- Units Affected
- a) 416,441 Bottles b) 674,177 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Location
- Tampa, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bausch & Lomb, Inc.. Units affected: a) 416,441 Bottles b) 674,177 Bottles.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 3, 2016. Severity: Low. Recall number: D-0647-2016.
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