Glass contamination prompts Fresenius recall
pharmafile | July 4, 2013 | News story | Manufacturing and Production |Â Â Fresenius, recallÂ
The US subsidiary of German drugmaker Fresenius has recalled a drug used in the treatment of Parkinson’s disease because of glass particle contamination in vials.
Fresenius Kabi USA said it is voluntarily recalling four lots of benztropine mesylate injection after establishing that visible glass particles were present in some 2mL single-use vials of the product, which is manufactured by Allergy Laboratories and can be administered either intravenously or intramuscularly.
The company also discontinued distribution of the 2mg/2mL product while it investigates the cause of the defect.
Glass contamination tends to occur as a result of delamination of vials, with slivers of glass breaking free as a result of the combination of chemical action – typically from strongly acidic or alkali solutions – and mechanical fracture prompted by defects in the vial surface.
There was a surge in product recalls caused by glass delamination between 2006 and 2011, prompting the FDA to recommend that pharmaceutical manufacturers review their relationships with glass suppliers to ensure that patient safety and product quality were not being compromised.
The defect discovered in the Fresenius Kabi product was reported as visible particles, but the company notes that the process of glass delamination may result in formation of both visible and sub-visible particles.
Small particles are a particular concern because if taken into the body, they have the potential to lodge in tissues and cause an inflammatory response or other adverse reactions. Damage to blood vessels can occur, which in severe cases could lead to organ damage or death.
Fresenius Kabi stresses that no adverse events, patient reactions or customer complaints have been reported to date with the benztropine mesylate product.
Somewhat worrying for the company however is that this is the second product recall due to glass delamination in the last couple of months. Towards the end of May it withdrew one lot of an injectable magnesium sulfate injection from the US market.
Phil Taylor
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