Regulatory Focus™ > News Articles > Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems

Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems

Posted 21 May 2013 | By Alexander Gaffney, RAC

Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at least the second related to the particulate contamination, according to previous reports.


In October 2010, Sandoz initiated a similar recall of its methotrexate vials, noting the "presence of glass particles" in the product.

"Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge," the firm explained. "While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal administration."

Sandoz noted that other potential adverse events included local damage to blood vessels in the lung, localized swelling, granuloma formation, foreign-body inflammatory response, local pain and swelling.

Related manufacturing problems have persisted in recent years, both at Sandoz and other manufacturers, leading the US Food and Drug Administration to take a series of unusual regulatory actions. In March 2012, for example, it started to allow the import of generic methotrexate from Canada to help alleviate shortages.

Editor's Note: A previous version of this story cited an example of FDA allowing the import of a drug from Sun Pharmaceuticals to alleviate shortages. That drug was doxirubicin, not methotexate. We regret the error.

Same Old Problems

But if those actions have been successful in helping to alleviate shortages, which a reading of FDA's updated drug shortages list shows them to have been, Sandoz hasn't had the same success in preventing recurring manufacturing problems with the drug.

Sandoz's 20 May 2013 recall notice cites a problem nearly identical to the one cited as the cause of the October 2010 recall: non-microbial particle contamination.

It was not clear from the notice if those particles were glass, but the company's notice says that symptoms "are not to be expected" from any microemboli that occur from the contamination. The warnings are considerably less dire than those indicated in 2010, raising the prospect that the contamination is not related to glass particles, but something else entirely.

The size of the two lots were not immediately clear from the recall notice, though Sandoz said they had been distributed to within the US and to Poland.

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