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FDAJuly 11, 2018drug

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

renaissance lakewoodrenaissance

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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... — Recall Details · AllClear