Heritage Pharmaceuticals issued a recall for two injectable drugs after microbial growth was detected in an unreleased lot of both products, according to a recall notice on the FDA's website.
The affected products are Amikacin Sulfate Injection Lot VEAC025 and Prochlorperazine Edisylate Injection Lot VPCA172. Both products were distributed to wholesalers in the U.S. in 2018.
The microbial growth may indicate a lack of sterility in other lots, according to Heritage.
"Nonsterile 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 company said in its recall notice.
Both drugs are manufactured by Emcure Pharmaceuticals and distributed by Heritage.