FDAFDA · Food and drugs·Recall number D-1031-2018
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Published August 8, 2018 · Recall initiated: July 11, 2018
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
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Renaissance Lakewood, LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # A061213, Exp 09/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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