Hospira ($HSP), which has been battling manufacturing problems, is recalling four injectable cancer drugs shipped throughout the U.S. and other drugs shipped to about 15 countries around the world.
In a joint release with the FDA, the company says in the U.S. it is recalling 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, shipped between September and April. The notice says vials have been found with "visible particles embedded in the glass located at the neck of the vial.''
In a statement sent to FiercePharmaManufacturing, spokesman Daniel Rosenberg says, "Hospira has not received any reports of adverse events related to these lots. The root cause is a supplier glass defect, and we have taken corrective action to prevent this from occurring again. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall."
Shortages have resulted from some earlier recalls. In fact, Hospira is one of four genericsmakers 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.
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.
- here is the FDA press release
- here's the Reuters story
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