FDAFDA · Food and drugs·Recall number D-0615-2017
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
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
- Brand
- LEVOFLOXACIN
- Manufacturer
- Claris Lifesciences Inc
- Distributor
- Nationwide
- UPC
- 0336000047241
- Lot
- Lot #: A060040, Exp. Dec 2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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