November 18, 2017

RECALL: Nexterone Recalled Due to Particulate Matter

Baxter International has voluntarily recalled 1 lot of the antiarrhythmic Nexterone (amiodarone) due to the potential presence of particulate matter.
By Kerry Lengyel
Baxter International Inc., a Fortune 500 health care company, is voluntarily recalling 1 lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection due to the potential presence of particulate matter. This lot was distributed to US wholesalers, distributors, and health care facilities between June 23, 2017 and October 2, 2017.

After performing a stability study, Baxter identified the particulate matter in a single lot to be consistent with polyethylene, which is the primary constituent of the film and ports used to manufacture the bag in which the medication is packaged.

If the medical practitioner does not use inline filtration, these particles could cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, and systemic embolization.

According to the FDA, “Nexterone is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.”

If administered intravenously, this contaminated solution could lead to adverse health consequences depending on the size, number and composition of the foreign material as well as the patient’s underlying medical condition.

The recall affects the lot of Nexterone with these qualities:
 
Product Code Product Description Lot Number Expiration Date NDC
2G3451 NEXTERONE (amiodarone HCl) Premixed Injection, 150 mg/100 mL NC109925 6/1/2019 43066-150-10

According to Baxter, there have been no reports of adverse events associated with this recalled lot. The company urges practitioners to stop use and distribution and quarantine the recalled product immediately.

The recalled product may be returned to Baxter for credit by calling the company’s health care center for service at 888-229-0001.
 

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