Reported Oct 19, 2016 · Terminated
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial,…
Leiter's Compounding
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Leiter's Compounding · 17 Great Oaks Blvd · San Jose, CA · 95119-1359
Is this the product you have?
- Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
- Lot codes and dates
- All unexpired lots; Expirations dates of 09/21/2016 to 2/2/2017
- Amount recalled
- 76,315 total units, all products
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
This product could cause temporary or reversible health problems — stop using it.
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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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