Fluconazole Injection recalled over sterility concerns

Recall date

March 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 0…

Recall number

D-0614-2017

FDA classification

Class II

Brand / firm

Claris Lifesciences Inc

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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