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FDAMarch 10, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

claris lifesciencesclaris

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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