Fresenius Kabi Initiates Massive Recall Due to Glass Particles

August 1, 2014

German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials.

Fresenius Kabi USA in May pulled 2,799,380 vials of fosphenytoin sodium injection USP 10 ml and 2 ml, the FDA said in an enforcement report. The agency classified the recall as a class II, which is reserved for products that might pose a temporary health problem but have a low chance of serious risk.

“The particles are believed to be caused by glass delamination, which is known to occur under specific conditions, including high temperatures, the use of vials made from tubling glass and solutions, such as this product, with higher pH levels,” spokesman Matt Kuhn said.

Fresenius hasn’t received any reports of adverse events connected with the glass particles in the product, Kuhn said.

The drugmaker has conducted similar recalls before. Last year it recalled four lots of benztropine mesylate injection, USP, 2 mg/2 ml (1 mg/1 ml) and a lot of magnesium sulfate injection due to the potential presence of glass particles.

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