Pfizer Recalls IV Drugs

Date: July 28, 2010By: H. Scott Bates

Pfizer has recalled Metronidazole, Ciprofloxacin and Ondansetron IV products after foreign matter was found floating in the bags. Floating matter can indicate that the product is non-sterile, putting patients with weakened immune systems who receive the drugs intravenously at risk for life-threatening infections. The FDA warned doctors and hospitals to stop using the drugs, as they could potentially kill patients with compromised immune systems.

Metronidazole and Ciprofloxacin are antibiotic drugs which can be administered intravenously to treat infections. Ondansetron is an injection used to relieve nausea and vomiting associated with chemotherapy or surgery. These drugs are provided in plastic IV bags to be administered intravenously.

Reports of white matter floating in a Metronidazole bag surfaced, and a subsequent analysis revealed the matter as Cladosporium mold. Mold of this variety can cause infections in weakened patients, such as those with HIV or Lupus. A complaint regarding white matter in an Ondansetron bag has also been filed and the product is currently under analysis. Because foreign matter can cause non-sterility, it should never be present in an injectable product.

Pfizer, which began distributing these Claris products across the county, has stopped distribution of all sterile-injectable products in IV bags licensed from Claris Lifescienes. The pharmaceutical company has also recalled the products already distributed.

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