Heritage Pharmaceuticals Inc. Recalls Products Due to Sterility Failure

May 30, 2019

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

Heritage Pharmaceuticals Inc. (East Brunswick, NJ) announced on May 28, 2019 that it was recalling Amikacin Sulfate Injection, USP, 1 g/4 mL (250 mg/mL), and Prochlorperazine Edisylate Injection, USP, 10 mg/2 mL (5 mg/mL) after microbial growth was detected in unreleased lots of both products. The products were manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. While Heritage has not received any reports of adverse events related to the recall, use of non-sterile injectable products that are intended to be sterile could result in infection, hospitalization, organ damage, or even death, according to the company.

The affected lot (VEAC025, Expiry Date: October 2019) of Amikacin Sulfate Injection, which is used to treat serious infections due to susceptible strains of Gram-negative bacteria, was manufactured in a sealed vial with a printed label affixed to the vial. Fifty-six cartons, which included 10 labeled vials, were shipped in one box to wholesalers and distributors in the United States between June and August 2018.

The affected lot of Prochlorperazine Edisylate Injection (VPCA172, Expiry Date: April 2020), which is used to control severe nausea and vomiting and treat schizophrenia, was manufactured in a sealed vial with a printed label affixed to the vial. Twenty cartons containing two trays of five vials each were distributed to wholesalers and distributors in the United States between October and November 2018.

Adverse reactions may be reported to FDA through its MedWatch program.

Source: FDA