Class III
Terminated
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
- Company
- Renaissance Lakewood, Llc
- Recall Initiated
- March 2, 2018
- Posted
- April 4, 2018
- Recall Number
- D-0605-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1277 bags
- Firm Location
- Lakewood, NJ, United States
Reason for Recall
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Distribution
Nationwide
Lot / Code Info
Lot A060644, May 2018
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