Contaminated drug lawyers at Pintas & Mullins Law Firm announce yet another recall initiated by a compounding pharmacy, this time Pallimed Solutions of Woburn, Massachusetts. The company is recalling all sterile compound products distributed since January 1, 2013.
The recalled products from this pharmacy were distributed to patients and healthcare facilities in 21 states, including California, Florida, Illinois, New York, Texas, and Wisconsin. The FDA is urging anyone who received Pallimed products to immediately discontinue use and return the product to Pallimed. All consumers receiving recalled products – which include eye treatments, erectile dysfunction, and hormone replacement therapies – can expect to be notified by the company via telephone, fax, or mail. A comprehensive list of all recalled products can also be found here.
Regulators reportedly found foreign matter in certain vials of drugs used for injections at the pharmacy, causing the state board to order Pallimed to stop producing its sterile products. The board also required Pallimed to quarantine the products in its possession, and initiate this recall to avoid any patient infections from the contamination. The pharmacy will continue to produce and distribute its non-sterile products.
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State and federal governments have significantly increased the oversight into compounding pharmacies after the outbreak of fungal meningitis in 2012, which continues to infect patients still today. The facility responsible for the outbreak, the New England Compounding Center, is also located in Massachusetts, only about 30 miles from Boston, where the Department of Public Health operates from. The fungal meningitis outbreak has so far killed about 50 people and injured more than 700 others.
The New England Compounding Center is now facing dozens of lawsuits from the mold contamination and recently filed for bankruptcy protection. Dozens if not hundreds of other affected patients are expected to file lawsuits in the months to come, as patients continue to be infected.
This most recent recall comes only about a week after another compounding pharmacy, Clinical Specialties, recalled its Avastin medications after one man died and dozens of others were sickened. This recall was announced after five initial reports were released of patients contracting eye infections from the drug, which was contaminated with bacteria. Avastin is an intravenous cancer drug, although Clinical Specialties allocated it into smaller doses to treat patients suffering from wet macular degeneration, an eye condition.
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A third compounding pharmacy recall was recently announced from New Jersey’s Med Prep Consulting, which suspended its operations when mold particles were visible in some of its IV medications. The pharmacy agreed to cease manufacturing and shipping while the syringes, bags, and vials of premixed solutions were recalled. Mold was found in at least five bags of vital injections drugs at a Connecticut hospital, which sparked the recall.
Due to the recent fatal contaminations, state and federal authorities have significantly increased the scrutiny over compounding pharmacies, which undoubtedly led to the two most recent recalls at Clinical Specialties and Pallimed. This increase in oversight, however, is long overdue, as experts state that the deadly outbreak of fungal meningitis was merely a calamity waiting to happen.
This is because compounding pharmacies are not as strongly regulated as major drug manufacturers, such as Pfizer or Johnson & Johnson. Compounding pharmacies mix specific drugs for individual patients, which is something larger drug companies do not do. Unfortunately, these new, specialized drugs are not subject to FDA-approval, and are mixed in facilities that are not consistently inspected.
In December 2012, the state ordered Pallimed to cease manufacturing of its sildenafil citrate drug (better known as Viagra), because it was being mixed with improper ingredients. Pallimed is one of the largest sterile compounding pharmacies in Massachusetts, so the recalls it initiates affect patients and facilities in areas throughout the country, not just in New England.
Dangerous drug lawyers at Pintas & Mullins Law Firm urge patients to stay up-to-date with recalls and safety alerts from compounding pharmacies, as the government continues to head investigations into these facilities. If you were harmed by a drug manufactured at Pallimed, the New England Compounding Center, Med Prep, or Clinical Specialties, you may have the right to compensation, and should contact a skilled attorney as soon as possible.