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    1. Regulatory

    Nationwide recall: Amikacin Sulfate Injection, Prochlorperazine Edisylate Injection fail sterility tests

    May 30, 2019
    Recall 5ceff0556857e

    The Food and Drug Administration says Heritage Pharmaceuticals Inc. has initiated a voluntary recall to the consumer level on the following injectables due to a failed sterility test:

    ·   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

    Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, organ damage or death.

    The 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, according to an FDA safety alert.

    To date, FDA says Heritage has not received adverse event reports related to this event.

    Amikacin Sulfate Injection

    This is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species.

    Amikacin Sulfate Injection was manufactured in a sealed vial with a printed label affixed to the vial. Ten (10) labeled vials were packed into a carton along with a leaflet. Fifty-six (56) cartons were packed into one shipper box. Heritage began shipping Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), NDC # 23155-290-42, Lot: VEAC025 on June 22, 2018, and the entire lot was distributed to wholesalers and distributors in U.S. between June 2018, and August 2018.

    Prochlorperazine Edisylate Injection

    This is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

    Prochlorperazine Edisylate Injection was manufactured in a sealed vial with a printed label affixed to the vial. Five (5) labeled vials were packed into one formed PVC tray. Two (2) PVC trays were packed into a carton along with a leaflet. Twenty (20) cartons were packed into one shipper box. Heritage began shipping Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), NDC # 2315529442, Lot: VPCA172, on October 31, 2018, which was distributed to wholesalers and distributors in United States between October 2018, and November 2018.