A recent announcement from the National Medical Products Administration has revealed that a batch of amiodarone hydrochloride injection produced by Shandong Beida Hi-Tech Huatai Pharmaceutical failed quality inspections.
The batch, sized at 3ml:150mg, was tested by the Fujian Provincial Institute for Food and Drug Quality Control and found to be non-compliant across several parameters, including related substances, iodide content, and assay determination.
Amiodarone hydrochloride injection is classified as a Category A medical insurance emergency medication, widely used to treat severe arrhythmias such as atrial arrhythmias with rapid ventricular response, tachycardia associated with Wolff-Parkinson-White syndrome, and life-threatening ventricular arrhythmias. It also plays a critical role in cardiopulmonary resuscitation for cardiac arrest cases where external defibrillation proves ineffective, earning it the reputation of a "lifesaving drug" among medical professionals.
The inspection results indicate multiple serious issues with the product. A failed assay determination signals insufficient active ingredient levels, which could mean patients may not receive adequate medication dosages during emergency situations, potentially delaying critical treatment. Elevated related substances suggest excessive organic impurities that could heighten the risk of toxic side effects. Abnormal iodide levels further compromise the overall quality and stability of the medication.
Earlier regulatory inspections had already identified significant problems at the manufacturer's facility. The freeze-dried powder injection workshop's production line 103 was found to have one serious defect. Investigations revealed that when production deviations occurred, the company failed to conduct comprehensive quality risk assessments, with inadequate risk control and handling measures in place. In response, the Shandong Provincial Drug Administration has suspended production of amiodarone hydrochloride injection on that specific production line.
Following these findings, the National Joint Procurement Office for Drugs issued a formal announcement canceling the company's selection status for amiodarone hydrochloride injection in the national centralized procurement program. The manufacturer has been placed on a "violations list" and will be barred from participating in national procurement applications from June 9, 2026 through December 8, 2027. Supply replacement procedures have already been initiated for the regions previously served by this product.
The information in this report is compiled from the National Medical Products Administration's notice concerning 37 batches of non-compliant pharmaceuticals (Document No. 30 of 2026), testing results from the Fujian Provincial Institute for Food and Drug Quality Control, inspection records from the Shandong Provincial Drug Administration, and related announcements from the National Joint Procurement Office.