Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.
East Brunswick, New Jersey-based Heritage Saturday issued the voluntary recall to the consumer level for sublots of infection fighter amikacin sulfate injection and schizophrenia drug prochlorperazine edisylate after microbial growth was found in unreleased supplies of the products.
The company warned that patients injected with either of the drugs could get site-specific or even systemic infections that could lead to hospitalization and death. The company said no adverse reactions have been reported so far.
Amikacin sulfate injection is for the short-term treatment of serious infections from a variety of species of gram-negative bacteria. Prochlorperazine edisylate injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia.
The recall does not say which Emcure facility manufactured the products. In 2015, the FDA banned nearly all products coming out of Emcure’s sterile manufacturing plant in Hinjawadi, India, and then followed up with a warning letter for the facility. The agency whipped the drugmaker for routinely using “fraudulent” test data to move drugs through the manufacturing process.
The agency then patted the company on the back for turning to consultants to help it solve its problems and changing some procedures and retraining employees. However, the FDA pointed out the facility should have known better because it had been previously warned about practices that could lead to drug contamination.
Emcure also has operations in Canada, having acquired Ottawa-based International Pharmaceutical Generics and its marketing operation Marcan Pharmaceuticals in 2016.
May 28, 2019