Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml Due to the Discovery of an Out of Specification Impurity Result Detected During Routine Quality Testing of Stability Samples at the 18-Month Interval

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 07 Mar 2016 09:02:24 -0600

Title:     Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml Due to the Discovery of an Out of Specification Impurity Result Detected During Routine Quality Testing of Stability Samples at the 18-Month Interval

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Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml Due to the Discovery of an Out of Specification Impurity Result Detected During Routine Quality Testing of Stability Samples at the 18-Month Interval
03/04/2016 06:32 PM EST

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100mL flexible container bag (NDC 25021-113-82) Lot 40608 manufactured by ACS Dobfar INFO S.A. and distributed by Sagent. Sagent has initiated this voluntary recall of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval.

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