Drug recall D-0615-2017

Class II Terminated reported Apr 5, 2017

Product

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.

Lots and codes

Lot #: A060040, Exp. Dec 2017

Recall details

Recalling firm
Claris Lifesciences Inc, North Brunswick, NJ
Quantity
24,456 units (1019 cartons x 24 bags)
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 10, 2017
Terminated
September 18, 2020

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