Hospira, the world’s leading provider of injectable drugs and infusion technologies, is recalling four injectable cancer drugs shipped throughout the U.S.
Hospira announced that it issued the nationwide recall of the four cancer drugs because of particles embedded in the glass at the neck of the vial.
The drugs recalled are carboplatin, cytarabine, paclitaxel, methotrexate and were distributed nationwide to wholesalers and direct customers.
These products are packaged in vials and are used to treat various types of cancer. In addition, methotrexate is also used to treat psoriasis and rheumatoid arthritis. Hospira issued a formal recall letter in the United States on June 27, 2012, along with notification to safety organizations.
The U.S. Food and Drug Administration said there may be potential for the drugs to come into contact with the embedded particles and the particles may become dislodged into the solutions.
The company announced at this point they had not had any reports of injury. However, injury could result if the solution were injected into a patient, the FDA said. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.
Hospira attributed the root cause to a supplier glass defect and said it was arranging for return and replacement of all recalled products, according to the FDA notice.
The recall of drugs from outside the U.S. is even broader, according to documents filed with its release. In addition to cancer drugs carboplatin, paclitaxel and methotrexate, Hospira is also recalling from certain countries, heparin, desferrioxamine, oxaliplatin, fluorouracil and epirubicin. Drugs are being recalled from 15 countries across the world including Canada, France, Belgium, Germany, half a dozen countries in Asia, as well as others. Canada last month had posted a warning that healthcare providers should be looking for vials of paclitaxel that might have particulates. Those drugs were shipped between November and May.
This latest recall is adding to the troubles that Hospira has experienced lately. And, even though they say this recall will not create a shortage, shortages have resulted from some earlier recalls. In fact, Hospira is one of four generics makers named in a House Committee report last month that has been tied to serious drug shortages in the U.S. because of FDA action requiring each to make improvements to its manufacturing.
Hospira has been upgrading its plants in Austin, TX, and Clayton and Rocky Mount, NC, after the FDA issued warning letters about shortcomings. The Rocky Mount plant closed in December for maintenance then resumed production in January after bringing in consultants and investing money to get a handle on FDA concerns.
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