Bausch & Lomb, Inc.: Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Is my product affected?

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

• Brand TROPICAMIDE

Check against the official notice below — it lists the full affected range.

What happened

Bausch & Lomb is recalling Tropicamide Ophthalmic Solution USP, 0.5%, a prescription eye medication sold in 15 mL bottles. The recall affects approximately 119,393 bottles distributed nationwide, including Puerto Rico, across eight specific lot numbers with expiration dates ranging from January 2016 through July 2017. The medication is being recalled because the package insert is missing updates that are present in the reference drug insert.

The recall notice does not specify a remedy or recommended action for consumers who have this medication.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Distribution: U.S. Nationwide including Puerto Rico. Quantity: 119,393 Bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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, 33637.2016-01-18
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• Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-302015-11-04

All FDA (Drug enforcement) recalls