FDAFDA · Food and drugs·Recall number D-0016-2017
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
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 09/21/2016 to 2/2/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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