In the past week, there have been reports of two compounding pharmacies recalling medications due to contamination issues. Following the fungal meningitis outbreak that killed more than 50 people last year due to contamination in a compounding pharmacy, extra caution must be taken.
One pharmacy that makes specialty medications has recalled nearly 100 compounded drugs after federal regulators found potential safety problems during an inspection.
Nora Apothecary Alternative Therapies of Indianapolis said it recalled all sterile drugs that have not reached their expiration date. The drugs were made on or before April 19, 2013.
The company said they initiated the recall after the U.S. Food and Drug Administration (FDA) found quality control problems that threaten the sterility of its products. If compounded drugs are not sterile, they can cause infections, though the company said it has not received any reports of illness.
The FDA is conducting a wave of inspections at compounding pharmacies across the country. The action follows the deadly meningitis outbreak we reported last year, caused by contaminated drugs from a Massachusetts compounding pharmacy.
Earlier this week, a Florida-based compounding pharmacy voluntarily recalled all lots of its sterile non-expired drug products sold nationwide due to concerns that the products might contain bacteria, as reported by federal regulators Sunday.
The FDA asked hospitals and other health-care providers who received sterile products, including all injectable products, from Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy of Lake Mary, Florida, to immediately check their medical supplies, quarantine the products and follow the company’s recall instructions. Patients who were administered any sterile drug products made and distributed by Balanced Solutions should contact their health-care providers.
Officials are not aware of any illnesses, an agency spokesman said. The company, which says it is licensed to operate in all 50 states, posted the recall on its website but did not say how many products were affected.
These pharmacies are two of the 30 compounding pharmacies—those that custom mix medication for individual patients—that the FDA inspected between February and April, as part of a targeted action after inspectors found filthy conditions at the New England Compounding Center, the Massachusetts pharmacy in the middle of last fall’s fungal meningitis outbreak. Tainted steroid injections made by NECC have killed 53 people so far.
Federal inspectors have found dozens of safety problems at these pharmacies. They focused on the firms that make high-risk sterile products, a key segment of the compounding industry. Several compounding pharmacies have issued recalls in the past several weeks, including last week’s recall in Dallas, Texas.
An FDA inspection of Balanced Solutions found “poor practices and conditions which may have exposed the company’s sterile products to microbial contamination,” the agency said in a statement. Inspectors discovered “black particles of unknown origin” in seven vials of an injectable steroid, according to their report. They also found “a cloth-like filament of unknown origin” in one vial of chromium-chloride injections, an additive used for intravenous nutritional supplements.
The FDA has identified gram-negative bacteria, a type of contaminant, in samples of the chromium chloride, officials said Sunday. Gram-negative bacteria can cause disease and many types of infection. It is not known what the black particles are, an FDA spokesman said.
Company officials did not immediately return an email and telephone calls Sunday. In a statement posted on their website, the firm said it was issuing the recall because of “concerns associated with quality control processes, which present a lack of sterility assurance.” It also said it had welcomed and cooperated with inspectors.
Last month, a Georgia compounding pharmacy recalled sterile products. The FDA alerted health care providers that a Georgia compounding pharmacy recalled all of its sterile products distributed in the U.S. since October 19th following reports of serious eye infections.
The FDA advised health care providers to stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company.
The FDA had previously reported five cases of serious eye infections from injections of the cancer drug, Avastin, which was prepared by Clinical Specialties Compounding Pharmacy (CSCP), used to treat macular degeneration. Clinical Specialties is a small compounding pharmacy that takes larger doses of Avastin for cancer patients and repackages them in single dose syringes for eye patients. The drug is injected directly into the inside of the eye. The drug is not approved for that use, but when cut into doses appropriate for the eye, it is significantly more cost effective than the approved drugs used to treat similar eye conditions.
As we previously reported, the FDA issued a warning in 2011 after reports that five patients went blind after receiving eye injections of Avastin in Los Angeles and 12 more Avastin patients developed eye infections in Miami.
The voluntary recall was expanded beyond Avastin to include all of CSCP’s sterile products after the FDA’s preliminary findings at the manufacturing site in Augusta, Georgia, raised concerns about a lack of sterility assurance, the agency said.
The recall included dozens of drugs, including antibiotics and numerous eye drugs.
The director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, said in a statement, “A compromised sterile product puts patients at risk for serious infections.” She added, “Health care professionals should ensure than any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered.”
Compounding pharmacies, which alter or mix drugs to meet the special needs of patients or prepare drugs for unapproved uses, such as with Avastin, have come under increased scrutiny since the tainted injectable steroids, which were manufactured at the Massachusetts compounder led to a meningitis outbreak last year, causing more than 50 deaths and injuring hundreds of patients.
The FDA said it was working with the U.S. Centers for Disease Control and Prevention and with state health departments to determine the scope of any contamination caused by products from the Georgia pharmacy.
Last month, Med Prep Consulting Inc. issued a recall after they found particles floating in five doses of a compounded solution. Med Prep recalled 83 different kinds of drugs compounded at its facility in New Jersey. A Connecticut hospital notified Med Prep that doctors had found visible particles floating in five bags of magnesium sulfate solution meant for intravenous use. The particles were later identified as mold.
If patients were given intravenous magnesium sulfate drips that contained mold, they could have a stroke, become septic or develop an infection in the liver, lungs, kidneys or tissue surrounding the brain, said Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University Medical Center in Nashville, Tennessee.
“Not only do you get the mold, but the mold has been growing in this fluid for awhile and some of its metabolic products are floating free in the liquid,” said Schaffner. He explained that in your blood stream, this would be very dangerous.
We need stricter regulations placed on these compounding pharmacies. If they are inspected and found to be filthy, they should be shut down before they put additional patients at risk. How do you feel about the overwhelming number of compounding pharmacies receiving FDA actions?
Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).