Two drugs, one injection fighter and another used to treat schizophrenia, have been recalled for potential contamination. The Indian company Emcure Pharmaceuticals produces the drugs. They’re then distributed by Heritage Pharmaceuticals here in the United States. The factory where the drugs are manufactured has long had problems with sterility.
The New Jersey-based Heritage Pharmaceuticals voluntarily recalled the drug in a press release made public on May 25. In their announcement about the recall, the distribution company outlined how two of the Emcure’s drugs appear to have microbial contamination. The recall affects prochlorperazine edisylate (PE), a schizophrenia drug, and amikacin sulfate (AS), an infection fighter.
They noted that anyone administered either one of these medications could end up contracting a site-specific or systematic infection. Either one of these could result in a patient’s hospitalization or death. They acknowledged that so far, there haven’t been any reported cases of adverse reactions to either drug.
The PE injection that has been recalled is often used to treat vomiting, nausea and some patients with schizophrenia. AS is the go-to drug that doctors use to treat serious infections caused by gram-negative bacteria.
This latest recall marks the second recall of Emcure drugs in the past five years. Most of the manufacturing company’s products were recalled in 2015 after their plant was found to have sterility issues. The U.S. Food and Drug Administration (FDA) then accused the drug maker of creating fraudulent data showing that their facility was safe.
Two types of recalls exist: mandatory and voluntary. The more danger that a drug poses to the public, the more likely it is that a mandatory recall will be issued.
Individuals who have been prescribed a recalled drug should return it to their pharmacy. They should then consult with their doctor about alternative medications that they can take instead. If your health has declined because of something that you took, then a defective drugs attorney can advise you of your right to sue the company that manufactured it.