Sun Pharmaceutical Industries Ltd is initiating a recall for 200 vials of gemcitabine due to concerns about sterility.
Gemcitabine is marketed as Gemzar by Eli Lilly and Company. The drug helps prevent cancer cells from replicating. The GemCarbo chemotherapy regimen is used to treat several different cancers, most notably lung cancer.
Sun Pharmaceutical initiated the recall, because the sterility of the vials may have been compromised. If the vials are contaminated, the patient’s health could be at risk. Cancer patients are especially vulnerable to infection, so the company has to act quickly to keep the drug off the shelves.
The Food and Drug Administration (FDA) classified the action a Class II Recall, meaning that exposure to the drug may cause temporary, adverse health effects.
This is Sun Pharmaceutical’s second recall this year. The company recalled more than 2,000 bottles of a generic diabetes drug in January, after a customer reported a bottle containing the wrong medication.
Contaminated medications are no small matter. In 2012, a fungal meningitis outbreak resulted from steroid injections distributed by a compounding center. Upon closer inspection, the FDA realized that the compounding center was acting as an unlicensed drug manufacturer.
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