Class II
Terminated
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
- Company
- Claris Lifesciences Inc
- Recall Initiated
- March 10, 2017
- Posted
- April 5, 2017
- Recall Number
- D-0614-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,096 units (3016 cartons x 6 bags)
- Firm Location
- North Brunswick, NJ, United States
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #: A051052, Exp. Aug 2017
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