May 30, 2019

FDA: Heritage Pharmaceuticals recalls Amikacin Sufate Injection, Prochlorperazine Edisylate Injection

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) on May 28 announced the recall by Heritage Pharmaceuticals Inc (East Brunswick, New Jersey) of Amikacin Sulfate Injection, USP 1 gm/4 mL (250 mg/mL), Lot: VEAC025, Expiry Date: October 2019; and Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL), Lot: VPCA172, Expiry Date: April 2020.

These drugs are manufactured by Emcure Pharmaceuticals Ltd (Hinjwadi, Pune, India) and distributed by Heritage.

The recall was initiated because of a sterility test failure. Microbial growth was detected in one unreleased sublot of VPCA172 and one unreleased sublot of VEAC025, which may indicate a lack of sterility in the other sublots.


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