FDAFDA · Food and drugs·Recall number D-0614-2017
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Published April 5, 2017 · Recall initiated: March 10, 2017
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: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Claris Lifesciences Inc
- Distributor
- Nationwide
- Lot
- Lot #: A051052, Exp. Aug 2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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