(Changes headline and first paragraph to make clear that company initiated recall, not FDA.)
July 16 Hospira Inc said it has issued a nationwide recall of four of its injectable 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.
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.
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.
Formal recall letters have been distributed within the U.S. along with notification to safety organizations. (Reporting By Debra Sherman; Editing by Gerald E. McCormick)