FDAFDA · Food and drugs·Recall number D-0014-2017
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
Published October 19, 2016 · Recall initiated: September 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leiter's Compounding
- Distributor
- Nationwide
- Lot
- All unexpired lots; Expirations dates of 10/03/2016 to 12/19/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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