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Recall Observatory FDA recall evidence

Drug 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

D-0615-2017

March 10, 2017

Class II

Product summary

Firm
Claris Lifesciences Inc
Event
Event 76733
Status
Terminated
Classification
Class II
Quantity
24,456 units (1019 cartons x 24 bags)
Official record key
drug-enforcement:D-0615-2017

Official wording

Reason: 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.

Code information: Lot #: A060040, Exp. Dec 2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility