Sanofi recalls allergy injection pens
pharmafile | October 29, 2015 | News story | Manufacturing and Production | Allerject, Sanofi, anaphylaxis
Sanofi has halted manufacturing and is recalling its Allerject auto-injectors following a blunder involving incorrect dosages.
The voluntary recall involves all Allerject (epinephrine injection), which are currently on the market in the US and Canada. This is thought to total around half a million devices, including both the 0.15 mg/0.15 mL and 0.3 mg/0.3 mL strengths for hospitals, retailers and consumers.
The products have been found to have potentially delivery inaccurate doses. The recall came after Sanofi received more than two dozen reports of patients who had an adverse reaction after using their injector. Patients have described symptoms of the underlying hypersensitivity reaction. However, no fatal outcomes have been reported among these cases.
The French firm received 26 reports of ‘suspected device malfunctions’ – 17 in the US and nine in Canada. It said that it was recalling 492,000 packs, most of which contain two devices.
The injection devices are used for patients who have serious allergic reactions, or anaphylaxis. While the French drugmaker said none of the “device malfunction reports have been confirmed,” it warned that anaphylaxis is serious and can be fatal for someone who is having a reaction and who does not get the proper dose of the drug.
In a video that accompanies its announcement, Sanofi’s chief medical officer Dr Paul Chew advises patients to contact their doctors for an alternative injection. However consumers complained on social media sites that the recommended alternative injections were more expensive than the Allerject pens. There also appeared to be difficulties contacting Sanofi’s US advice line.
Sanofi has also issued a precautionary voluntary recall, and says it is “actively working with suppliers of alternative epinephrine auto-injectors to have a full stock available in Canada as soon as possible.”
Yasmita Kumar
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