Sun Pharmaceutical Industries Inc. is recalling 16,450 vials of Norepinephrine Bitartrate Injection, USP (4 mg/4 mL). This medication, which is used to treat life-threatening low blood pressure in emergency settings, is being recalled because routine testing found levels of an impurity called norepinephrine sulfonic acid that exceed approved specifications. No injuries or incidents have been reported to date.
Using medication that contains impurities above the approved limits could potentially reduce the effectiveness of the drug or cause unexpected reactions, though the risk to patients in this specific instance is considered low.
Manufactured by Gland Pharma Limited, India; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ.
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Sources: FDA iRES · Raw API Response
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