Manufacturing woes hit Baxter again

pharmafile | April 14, 2015 | News story | Manufacturing and Production, Sales and Marketing FDA, Gemünden, Pfizer, alesse, baxter, manufacturing, recall, vectura group 

Baxter is voluntarily recalling several lots of intravenous solutions due to the potential presence of particulate matter. 

The news has heaped more woe on the US-based firm that had only just recalled three lots of sodium chloride injection which amounted to around 600,000 units. Baxter has now recalled eight more lots which it adding to a national shortage of saline.

Previously the issue was reported as being down to bags that leaked, and on this occasion the drugmaker says the problem is “due to the potential presence of particulate matter”.

The company has issued a statement that was reiterated on the FDA website in its recall notice: “While Baxter manufacturing personnel were performing routine maintenance, particulate matter was detected and identified as material from a solution transmission system pump. There have been no adverse events or product complaints associated with this issue reported to Baxter.”

Baxter began the customer notification process on 24 March and says customers have been directed not to use products from the recalled lots. It adds the extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition.

“In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of pre-existing infections, allergic reactions, and systemic embolisation. In high-risk patients this may lead to serious adverse health consequences.”

Manufacturing round up

The firm is not the only one to claw back product lately as US giant Pfizer has been at the receiving end of some ‘supply chain issues’ just last week.

A Canadian drug distributor began recalling a small quantity of Pfizer’s birth control pills Alesse (levonorgestrel and ethinyl estradiol) after it accidentally shipped out expired units. 

Pfizer said in a statement that the store chain had ‘quickly informed’ the company after realising the mistake and ‘took immediate corrective measures’, according to Canadian Press.

Meanwhile in Europe there’s also been some bad news, this time from UK-based Vectura Group that has announced its intention to close its site in Gemünden, Germany by March next year.

The facility is currently involved in the production of the company’s nebuliser devices, supporting clinical trials and marketing. It says that in order to improve manufacturing efficiencies, all activities carried out in Gemünden will now be transferred to Vectura’s facilities in Gauting, Germany, along with Chippenham and Cambridge in the UK.

Some will also go to a contract manufacturing organisation for any commercial production – but the net result of all this is that the firm will close the site by March 2016.

Dr Chris Blackwell, chief executive of Vectura, says: “The decision to close our Gemünden site was a strategic and necessary one.  It will rationalise our business operations and deliver more cost-effective production of our nebulisers.  We retain the capabilities and capacity at our three remaining sites to support all our business operations.

“I would like to thank all the employees at Gemünden for their hard work and assure them of our continuing support as we prepare for the closure of the site in early 2016.”

Brett Wells

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