Recall of Medications made by Claris Lifesciences due to Presence of Cladosporium Mold

Posted On July 6th, 2010 By CSSFIRM.COM

Contaminated batches of Pfizer medications Metronidazole, Ciprofloxacin and Ondansetron were recalled last month because of bacteria found in the injection bags that hold the drugs. The bags were manufactured by Claris Lifesciences and sold under the names Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals.

These intravenous (IV) medications were found with foreign matter floating in the liquid, making them non-sterile. Any IV drug must be sterile or patients taking the drug may suffer potentially fatal infections.

Ironically, two of the medications, Metronidazole and Ciprofloxacin, are IV antibiotics for treating infections. Ondansetron is used to treat nausea in chemotherapy patients.

The bags containing the contaminated drugs were manufactured by Claris in Ahmedabad, India. Analysis of the foreign matter showed it to be Cladosporium mold, which can cause serious infections in patients with compromised immune systems, such as those suffering from infections or on chemotherapy.

The following medications were affected by the recall:

  • Metronidazole injection USP 500 mg/100 ml (NDC 0069-2390-01)
  • Ciprofloxacin in Dextrose (5%) injection, USP 200 mg / 100 mL (NDC 0069-4395-19)
  • Ciprofloxacin in Dextrose (5%) injection, USP 400 mg / 200 mL (NDC 0069-4396-27)
  • Ondansetron in 5% Dextrose injection 32 mg / 50 mL (NDC 0069-0700-12)

Pfizer began sending the products out to hospitals, distributors and wholesalers in the U.S. but has halted distribution for all sterile-injectables in Claris Manufactured IV bags while the FDA monitors the recall. Of the 1.7 million Claris IV bags affected, only about 20% were distributed before the foreign matter was discovered. No information has been released to reveal if all of the contaminated bags were recovered or if any were administered to patients. To date, no injuries have been reported because of the mold-contaminated medication.

More recently, Pfizer was ordered to recall a cancer drug, Mylotarg, when clinical trials showed little benefit to patients along with a high safety risk. Patients taking the drug suffered higher mortality rates, causing the trial to be halted early. This potentially dangerous drug was on the market for ten years before it was finally recalled.

Pfizer has had many other failures since last year including some experimental drugs and others in post-approval clinical trials for late-stage cancer. The medications Sutent and Axitinib were included among the failed cancer drugs. Pfizer also abandoned research on an Osteoarthritis drug Tanezumab. In addition, the company’s Alzheimer’s drug, Dimebon showed disappointing results in trials. Yet the drug continues to be tested alongside other Alzheimer’s medications to see if any benefit can be salvaged.

The string of failures raises grave concerns for patients taking new drugs that are intended to bring new hope for healing. But when these drugs are inadequately tested, patients may instead find their lives cut short by the drugs.

If you or a loved one suffered serious injury or death because of unsafe, inadequately tested or inadequately labeled pharmaceutical medications, contact us for help. We will evaluate your case free of charge and help you determine if you are entitled to recover damages because of injuries arising out of an unsafe drug.

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