Bimatoprost Solution/ Drops
FDA Recall NDC 0781-6206
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bimatoprost (NDC 0781-6206). A significant event, classified as Class III, was initiated on Oct 17, 2019 by Sandoz Inc. The reported reason for this action was: "Labeling: Incorrect or missing package insert."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or missing package insert.
Oct 17, 2019
Nov 06, 2019
346,929 bottles
Recall Profile & Regulatory Data
Event ID
84082
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jan 19, 2022
Product Description
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.
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
0781-6206-75Product
0781-6206-93Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
