Sudden injection drug recall!

The compliance of preservation conditions restricts the circulation of medicines

We know that medicines must have corresponding storage and transportation conditions.

Picture source FDA

On December 2, the FDA announced the recall notice of Sandoz's enoxaparin sodium injection

Picture source FDA

The intended use of Enoxaparin Sodium Injection is to prevent deep vein thrombosis.

According to the results of the official website of the China Food and Drug Administration, the specification has not yet been launched in China

Tuyuan Xinhua News Agency

What’s strange is that, among several enoxaparin sodium injections that the author has inquired about, including SANOFI SYNTHELABO, Shenzhen Tiandao, and Nanjing Jianyou Biochemical products, all products are stored below 25℃, while Suzhou Erye Pharmaceutical’s products do not exceed 20℃.

In the past recalls of injections, most of the problems occurred in the production process of enterprises, such as:

Microparticles are found in daptomycin for injection;

Precipitation in furosemide sodium chloride injection;

Microparticles are found in lactated Lin Ge injection;

Ketorolac tromethamine injection found particles;

There is an undeclared preservative benzyl alcohol in heparin sodium products;

The impurity of methylprednisolone sodium succinate injection exceeds the standard;

Cross contamination of dexmedetomidine hydrochloride injection and lidocaine;

The product packaging of tranexamic acid for injection and amiodarone hydrochloride is confused;

Neostigmine methyl methyl sulfate prefilled injection is mislabeled, etc.

The high molecular polymers in Ceftazidime for Injection and Glucose Injection exceed the standard

These are all produced during the production process of the company, but the quality control process has not been found to lead to a recall, which belongs to the improper supervision of the company itself

As a manufacturer, we require the temperature data on the road during cold chain transportation to be sent to the consignee and the consignor after the goods arrive

It is not clear whether the challenge test for storage conditions during the research and development process includes these harsh temperatures, but this method of recalling when encountering risks is still worth emulating