Claris Lifesciences Inc recalls Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08

Recalled April 5, 2017 · FDA recall D-0614-2017 · Claris Lifesciences

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. · FDA Class II

Units

18,096 units (3016 cartons x 6 bags)

Sold at

Nationwide

Description

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.

Product

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

Manufacturer(s)

Claris Lifesciences Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →