FDAFDA · Food and drugs·Recall number D-0012-2017
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
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 09/24/2016 to 02/06/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.