Class II
Terminated
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10
- Company
- Renaissance Lakewood, Llc
- Recall Initiated
- February 21, 2018
- Posted
- April 25, 2018
- Recall Number
- D-0696-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1784 bags
- Firm Location
- Lakewood, NJ, United States
Reason for Recall
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Lot #: A0A0539, Exp. 05/19
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