Hospira Recall - potential for serious injury

December 14, 2012 - Lake Forest, Ill - Hospira, Inc. (NYSE: HSP), issued this press release today to further inform the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira customers were notified of the issue in early November 2012.

In the event where particulate matter is injected into a patient, there may be the potential for serious and/or life threatening patient injury. In general, if particulate matter from crystallization is injected, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible.

Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.

The affected lots were distributed Nationwide and in Puerto Rico between the dates of March 2012 and September 2012.

Hospira has not received reports of any adverse events or product quality complaints known to be associated with the issue for these lots. This recall is being conducted as a precautionary measure.
Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-8362 between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the FDA.

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees.

If you or someone you know has suffered serious injury due to a defective drug call the experienced defective drug attorneys at Buttafuoco & Associates 1-800-669-4878.

generic Lipitor (atorvastatin) recalled after glass discovered...

Ranbaxy Laboratories (generic drug maker) will stop manufacturing its version of Pfizer Inc's cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall.

Earlier this month, after the company discovered contamination with tiny glass particles, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg.

During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh

FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues.

The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny due to past problems that nearly derailed it ability to sell atorvastatin in the United States.

In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in drug applications.

Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.

If you or someone you know has suffered injury due to a defective drug/medication call the experienced defective product attorneys at Buttafuoco & Associates 1-800-669-4878

Contaminated steroid injection claim 23 victims injury nearly 300

Twenty-three people have now died and more then 280 have been sickened in the nationwide meningitis outbreak tied to contaminated steroid injections produced by a Massachusetts specialty pharmacy, U.S. health officials reported Saturday.

Fungus found in steroid injections produced by this Massachusetts specialty pharmacy matched the fungus linked to the outbreak. The officials said they'd confirmed the presence of the fungus, Exserohilum rostratum, in unopened vials of a steroid produced by the New England Compounding Center.

The vial came from one of three lots recalled by the Framingham-based company last month, officials from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration said.

The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the three lots, and nearly 97 percent of them have been contacted for medical follow-up.

The steroid, methylprednisolone acetate, is injected into patients for back and joint pain.   However, the contaminated steroid was also used on patients  for pain in their knees and shoulders. The company has since shut down operations and stopped distributing its products, health officials said.

Meningitis is a potentially fatal inflammation of the lining surrounding the brain and spinal cord.

On Friday, the New England Journal of Medicine published two articles on the outbreak, including a report on what's believed to be the first case in the outbreak -- a man in his 50s with a history of back and joint pain. He showed up at Vanderbilt University Medical Center in Nashville complaining of head and neck pain. Despite a series of medical interventions, he died after a 22-day stay at the hospital.

An autopsy revealed the presence of the fungus Aspergillus fumigates. It's the only case of this type of fungus detected in the outbreak so far; all other cases apparently involved the fungus Exserohilum rostratum, the journal said.

At this point, the best treatment seems to be at least three months of antifungal therapy, the doctors who wrote the commentary said.

The FDA said it was advising all health care professionals to follow up with any patients who were given any injectable drug from or produced by the New England Compounding Center. These drugs include medications used in eye surgery, and a heart solution purchased from or produced by the company after May 21.

Health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.

Infected patients have developed a range of symptoms approximately one to four weeks following their injection. People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.

Infected patients must receive intravenous drugs in a hospital.

Buttafuoco & Associates is now accepting meningitis cases caused by this contaminated steroid.  If you or someone you know have suffered injury due to a defective drug call the experienced Attorneys at Buttafuoco & Associates 1-800-669-4878.