FDA-Drug2017-04-05Class II
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
Claris Lifesciences Inc
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.
Sold states
Nationwide
Affected count
18,096 units (3016 cartons x 6 bags)
Manufactured in
1445 US Highway 130, North Brunswick, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2017Don't want to check this manually?
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