Reported Nov 6, 2019 · Terminated
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: a) 290635FA290635FBExp. 11/30/2019293230FExp. 6/30/2020294628F301337FExp. 11/30/2020304451FAExp. 1/31/2021. b) 290636FA290636FB290636FCExp. 11/30/2019293233FA293233FBExp. 5/31/2020293234FA293234FBExp. 6/30/2020294630F301338FA301338FB309426FExp. 11/30/2020304455FA304455FB Exp. 2/28/2021304883FExp. 4/30/2021312790FExp. 5/31/2021
- Amount recalled
- 346,929 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or missing package insert.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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