Heritage Recalls 2 Drugs Over Microbial Growth

Heritage Pharmaceuticals has recalled one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, USP, 10mg/2mL (5mg/mL) due to microbial growth having been detected in each lot. The drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage. “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, an FDA recall notice says. “To date, Heritage has not received adverse event reports related to this event.”

Amikacin sulfate injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Prochlorperazine edisylate injection is indicated to control severe nausea and vomiting and for treating schizophrenia.