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Resource Library > QA/QC

CSL & Hospira both recalling drugs in separate incidents

By Nick Taylor , 18-Apr-2012

CSL Biotherapies and Hospira are both separately recalling drugs due to contamination and syringe overfilling respectively.

In the past 24 hours both companies have begun recalling products after confirming quality control problems. The CSL recall of six batches of Albumex comes a month after the Australian Therapeutic Goods Administration (TGA) quarantined the product to investigate ethylene glycol contamination.

CSL has now tested 96 of the quarantined batches and found that close to one-fifth of the products are contaminated with low levels of ethylene glycol. Most of the contaminated drugs are housed at CSL warehouses but five batches were shipped overseas and another distributed in Australia.

Recalls of the six distributed batches are underway. The decision to recall Albumex 4 500ml, a drug used when blood volume is low, was made after ethylene glycol was found at a concentration of greater than 0.5mg/l.

Hospira morphine recall

On the same day in the US Hospira began a recall of one lot of morphine sulphate injection after customer reports of overfilled syringes containing more than 1ml. Hospira distributed the lot, each box of which contains 10 prefilled cartridges, to “a limited number of hospitals” in 10 states.

Hospira has not received any reports of adverse events related to this issue for this lot. This is believed to be an isolated event, and Hospira has initiated an investigation to determine the root cause and preventive actions”, the company said in a statement.

The recall comes as Hospira works to improve its manufacturing after a difficult few years. Last week Hospira hired John Elliot, formerly of GlaxoSmithKline, as its senior vice president of operations. Elliot will lead the efforts to improve quality at existing plants and finish building a new facility in India.

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