The notice was posted by Health Canada after hearing complaints from customers in other countries. Problems noted by customers include particles embedded in the vials or floating free in the solution. The location of the particles affects the risks, with those floating free the most potentially harmful.
“Injected particulate matter may acutely cause direct mechanical damage on entry to the body, sub-acute low level allergic response through mechanical disruption of tissue or immune response to the particles…and possible embolism,” Health Canada wrote in its warning to healthcare professionals.
Hospira is yet to receive adverse events reports linked to the three affected lots of the chemotherapy drug but the potential for harm is real. If the vial contains particles Health Canada recommends using an in-line filter to stop the contaminant reaching the patient.
The recall follows a succession of quality control failings at Hospira, the most recent of which led to the distribution of over-filled morphine cartridges. Hospira is working to fix problems raised by the US Food and Drug Administration (FDA), which has previously been critical of paclitaxel production.
In a 483 sent to Hospira one-year ago the FDA criticised an API (active pharmaceutical ingredient) plant in Boulder, Colorado for failing to complete validation of procedures for cleaning equipment.
The Boulder site is focused on API manufacturing so the fill/finish step, when a vial defect should be spotted, will take place elsewhere. Hospira acquired the Boulder facility – and paclitaxel – through the $2bn (€1.6bn) takeover of Australia-based Mayne Pharma in 2006.
Until 2003 Hospira sold paclitaxel developed by the NaPro Bio Therapeutics and Abbott Laboratories alliance. Hospira sold the rights for paclitaxel in 2003 but before that manufactured the product at a plant in McPherson, Kansas, FDA records show . In January the FDA issued a 483 to the Kansas plant.
Big Pharma recalls
The notice from Health Canada comes 10 days after it warned about Bacille Calmette-Guérin (BCG) vaccine from Sanofi Pasteur. Sanofi is recalling all the tuberculosis vaccine because of fears problems at its manufacturing facility have affected the quality of the product.
Health Canada said Sanofi is recalling 4,700 vials and has kept another 1,000 out of circulation. As of June 15 Health Canada had received reports of three adverse reactions potentially linked to the drug. Sanofi and Health Canada are now working together to fix the problems at the manufacturing facility.
Merck & co has also recalled a batch of vaccines this month. The recall of 39,000 doses of the vaccine for measles, mumps and rubella was initiated because Merck shipped the product before finishing an internal approval process.