FDA Drug Class III — Least Serious

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Hazard

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

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Products

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Bruns
Brand
Renaissance Lakewood, LLC
UPC
Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19

Units Affected

12088 bags

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