D-0615-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2017
- Initiation Date
- March 10, 2017
- Termination Date
- September 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,456 units (1019 cartons x 24 bags)
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot #: A060040, Exp. Dec 2017