Reported Oct 19, 2016 · Terminated
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (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?
- Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
- Lot codes and dates
- All unexpired lots; Expirations dates of 10/03/2016 to 12/19/2016
- 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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