Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) by Heritage Pharmaceuticals: Recall - Due to Sterility Test Failure AUDIENCE: Consumer, Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall to the consumer level of: Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.

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