Sandoz Inc: Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alco

Is my product affected?

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

• Brand BIMATOPROST

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

What happened

Sandoz Inc. is recalling Bimatoprost Ophthalmic Solution 0.03% due to incorrect or missing package inserts. The recall affects 346,929 bottles distributed nationwide in the U.S., available in both 3 mL and 5 mL sizes. Multiple lot numbers are affected with expiration dates ranging from November 2019 through May 2021.

The recall record does not specify a remedy or instructions for affected consumers.

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

Hazard

Labeling: Incorrect or missing package insert.

Details from the source

Reason for recall: Labeling: Incorrect or missing package insert. Distribution: Nationwide in the U.S. Quantity: 346,929 bottles Lot/code info: Lot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F, 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021.

Source

Official record: FDA (Drug enforcement) ↗

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

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