Reported Nov 6, 2019 · Terminated
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured…
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?
- Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
- Lot codes and dates
Lot #s: 287880F287881FExp. 10/31/2019290555FExp. 11/30/2019293389FExp. 2/29/2020290556F290557F293386F293387FExp. 3/31/2020293388F293390FExp. 5/31/2020293391FExp. 6/30/2020293392FExp. 7/31/2020295342F298823FExp. 8/31/2020295344F295345F295346FExp. 10/31/2020295347F304496FExp. 11/30/2020298825FExp. 12/31/2020304495F304497FExp. 01/31/2021304963FExp. 3/31/2021304966FExp. 4/30/2021304964FExp. 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.
Free recall alerts
Get alerted about new Sandoz Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.