Bausch & Lomb, Inc.: 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

Is my product affected?

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.

• Brand TROPICAMIDE

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

What happened

Bausch & Lomb is recalling Tropicamide Ophthalmic Solution USP, 1%, a prescription eye medication sold in 2 mL and 15 mL bottles nationwide including Puerto Rico. The recall affects over 1 million total bottles across multiple lots because the package inserts are missing updates that appear in the reference drug insert.

The source document does not specify what consumers should do regarding this recall.

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: a) 416,441 Bottles b) 674,177 Bottles Lot/code info: a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #: 199961, Expiry: 02/2016; Lot #: 220111, Expiry: 02/2016; Lot #: 222281, Expiry: 04/2016; Lot #: 222291, Expiry: 04/2016; Lot #: 224841, Expiry: 06/2016; Lot #: 228281, Expiry: 07/2016; Lot #: 228291, Expiry: 07/2016; Lot #: 231531, 10/2016; Lot #: 232671, Expiry: 11/2016; Lot #: 232681, Expiry: 11/2016; Lot #: 238931, 01/2017; Lot #: 238941, Expiry: 01/2017; Lot #: 240331, Expiry: 02/2017; Lot #: 242341, Expiry: 04/2017; Lot #: 242351, Expiry: 04/2017; Lot #: 243391, Expiry: 05/2017; Lot #: 246171, Expiry: 06/2017; Lot #: 246341, Expiry: 07/2017.

Source

Official record: FDA (Drug enforcement) ↗

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

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