江苏华兰药用新材料股份有限公司

 

SFDA Municipal Letter [2008] No. 118

 

To province, autonomous region & municipality-level SFDA (SDA):

 

During evaluation sampling program of domestic pharmaceuticals in 2008, it was found defective rate of clarity of ceftriaxone sodium for injection is high. National Institute for the Control of Pharmaceutical and Biological Products, Hebei Institute for the Control of Pharmaceutical and Biological Products and Hubei Institute for the Control of Pharmaceutical and Biological Products conducted analysis and study on quality status of ceftriaxone sodium. They thought such fact was directly caused by volatile substance released from butyl rubber stopper and insoluble complex formed by ceftriaxone sodium, which was directly bound up with the compatibility between ceftriaxone sodium and butyl rubber stopper.

 

Now, we have started to organize related authorities to conduct special study on impacts of clarity of ceftriaxone sodium caused by butyl rubber and will further take necessary measures to guarantee product quality.

 

To guarantee public pharmaceutical safety and avoid hidden dangers of product quality caused by butyl rubber stopper, all SDA shall dispose the defective products as follows:

 

1. Ask manufacturers of ceftriaxone sodium for transfusion in the areas under their respective jurisdiction to conduct self-check and call all defective products caused by butyl rubber stoppers back.

 

2. For products called back by the enterprises, SDA shall well supervise and control and never punish related manufacturers or distributions in accordance with Administrative Penalties Law. For eftriaxone sodium for transfusion with defective clarity found in in the link of drug distribution and using after Dec 1, 2008, investigate and handle according to Drug Administration Law.

 

3. For products after sampling check, of which the results were against regulations, treat as per related regulations and punish the enterprise according to product quantity represented by sampled specimen in Drug Inspection Report.

Drug Market Supervision Office of SFDA

Sep 17, 2008