Glass flakes in injectable MTX; drug recalled

Oct. 28, 2010 — Glass flakes have led to the recall of Sandoz and Parenta brand injectable methotrexate, a drug used to treat rheumatoid arthritis, cancer, and psoriasis.

The glass flakes “are the result of delamination of the glass used to manufacture the vials” of two dosages of the drug, the FDA says in a news release.

“There is the potential to develop adverse reactions in areas where the particles lodge,” the FDA says. “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 [spinal] administration.”

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