FDAFDA · Food and drugs·Recall number D-0605-2018
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
Published April 4, 2018 · Recall initiated: March 2, 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 and Failed Stability Specifications; out of specification results for assay and water vapor permeability
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Renaissance Lakewood, LLC
- Distributor
- Nationwide
- Lot
- Lot A060644, May 2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.