Compounding pharmacies that mass-produce medications have been linked to several deadly disease outbreaks. Our lawyers are now evaluating compounding pharmacy lawsuits on behalf of people who were injured by fungal meningitis, joint infections, bacterial blood infections, abscesses, eye infections, skin reactions, and other serious side effects of contaminated compounded medicines.
What You Can Do & How a Compounding Pharmacy Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting compounding pharmacy induced injury cases in all 50 states. If you or somebody you know was injured by a compounding pharmacy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Downing Labs Recalls Compounded Drugs for Contamination Risk
October 21, 2015 — After years of concern about sterility, Downing Labs LLC has issued a recall for compounded drugs that may not be sterile. Click here to read more.
September 12, 2014 — Martin Avenue Pharmacy, Inc. has recalled all sterile medications after the FDA found problems with quality control procedures that could compromise the safety of sterile medications. Click here to read more.
September 11, 2014 — For the third time in the last 15 months, the FDA is demanding a recall of all “sterile” products from NuVision Pharmacy because the safety and sterility of the medications cannot be assured. Click here to read more.
July 31, 2014 — The Louisiana Record reports that a lawsuit has been filed by a woman who was injured by contaminated medicine from Main Street Family Pharmacy, a compounding pharmacy that recalled all of its medicines last year. Click here to read more.
July 21, 2014 — Unique Pharmaceuticals has recalled medications because they may not be sterile, according to a Safety Alert from the FDA after inspections of the facility in Texas found “insanitary” conditions. Click here to read more.
July 21, 2014 — The FDA has issued another warning advising healthcare professionals not to administer medications marketed as sterile by Downing Labs, LLC, also known as NuVision Pharmacy, because they may be contaminated. Click here to read more.
July 1, 2014 — As part of enhanced regulation of the compounding pharmacy industry, the U.S. Food and Drug Administration (FDA) has issued documents describing manufacturing expectations, enforcement policies for safety violations, and proposed revisions to a list of drugs that may not be compounded. Click here to read more.
Februrary 10, 2014 — Rx Formulations, a compounding pharmacy located in Mesa, Arizona, has announced a voluntary recall for calcium gluconate 10% injections after FDA inspectors found microbial contamination. Click here to read more.
November 19, 2013 — New law regulating compounding pharmacies will require high-volume companies who mass-produce drugs to register with the FDA as “outsourcing facilities,” and they will be subject to stricter quality control and inspection requirements. Click here to read more.
September 30, 2013 — In May 2013, all medicines from The Compounding Shop were recalled due to concerns about sterility. On September 3, FDA inspectors issued a “483” warning letter after finding serious problems, including bottles of budesonide solution that were cloudy and contained floating, white fungus. Click here to read more.
September 10, 2013 — Park Compounding Pharmacy recalls testosterone injections. Click here to read more.
September 9, 2013 — Avella Specialty Pharmacy recalls compounded drugs. Click here to read more.
September 5, 2013 — Medaus Pharmacy of Birmingham, Alabama has recalled certain lots of injection medicines because they cannot assure the sterility of the products. Click here to read more.
August 11, 2013 — Specialty Compounding, LLC, a compounding pharmacy based in Cedar Park, Texas, has recalled all sterile medicines compounded since May 9, 2013 because of possible bacterial contamination. At least 15 people at two hospitals in Corpus Christi, Texas developed bacterial blood infections after receiving intravenous (IV) calcium infusions. Click here to read more.
June 6, 2013 — Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tennessee, issued a recall after samples of an epidural steroid injection were linked to 7 cases of skin and soft tissue abscesses. Click here to read the FDA Warning.
March 21, 2013 — Clinical Specialties Compounding Pharmacy, which is based in Georgia, has recalled all medicines after receiving 5 reports of eye infections inside the eyeball of patients who received re-packaged Avastin for the treatment of macular degeneration. Click here to read the FDA Warning.
October 4, 2012 — New England Compounding Center (NECC), a compounding pharmacy based in Massachusetts, has been linked to an outbreak of fungal meningitis. As of August 2013, at least 749 people have been sickened and 63 people have died from meningitis, fungal infections, joint infections, and/or strokes. Click here to read more.
What is a Compounding Pharmacy?
Compounding pharmacies are modern-day apothecaries. They make custom drugs for individual patients based on a doctor’s prescription. Functions of a compounding pharmacy may include:
- Take a solid drug and turn it into a liquid for a patient who can’t swallow
- Split a drug into smaller doses (Avastin, for example)
- Create a new drug from raw pharmaceutical materials
- Compound complex intravenous (IV) therapies for hospitals
- Remove allergens or preservatives for sensitive patients
- And more
What is the problem with Compounding Pharmacies?
Compounding pharmacies are essential when a doctor needs a custom medication. By law, compounding pharmacies must have a prescription to make a drug — they cannot mass-produce drugs like a small pharmaceutical company without specific licenses and increased oversight from the FDA.
Unfortunately, a growing number of disease outbreaks have been linked to compounding pharmacies that mass-produced medications and sold them to clinics and hospitals without individual patient prescriptions. In 2012, an outbreak of fungal meningitis in 23 states was linked to more than 17,000 vials of a steroid injection manufactured by New England Compounding Center (NECC).
What is the FDA Doing?
The U.S. Food and Drug Administration (FDA) dramatically stepped up inspections of compounding pharmacies in 2013, following a deadly outbreak of fungal meningitis in 2012. They have sent “483” Warning Letters to dozens of compounding pharmacies when problems were found during inspections.
Compounding Pharmacies and Meningitis
Meningitis is a life-threatening condition that occurs when a bacteria, virus, or fungus infects the central nervous system. The infection causes the lining around the spinal cord and brain (meninges) to become inflamed. Meningitis can cause permanent brain damage, seizures, and death.
Symptoms of fungal meningitis:
- Stiff neck
- Nausea and vomiting
- Light sensitivity (photophobia)
- Altered mental status
Compounding Pharmacies and Blood Infections
Bacterial blood infections can occur any time bacteria enter the body — through an open wound, during an operation, or in a contaminated injection medication. In severe cases, the bacteria travel throughout the body and infect vital organs and blood vessels. This can lead to septic shock — a whole-body inflammatory response that can cause blood clots, respiratory distress, organ damage, heart failure, and death.
Symptoms of a bacterial blood infection:
- High fever
- Low body temperature (body chills)
- Increased heart rate (tachycardia)
- Low blood pressure
- Abnormal white blood cell count
- Respiratory distress, rapid breathing, or shortness of breath
- Nausea, vomiting
- Abdominal pain
- Malaise (feeling or looking ill and anxious)
- Sepsis and septic shock
- And more
Do I have a Compounding Pharmacy Lawsuit?
The Schmidt Firm, PLLC is currently accepting compounding pharmacy induced injury cases in all 50 states. If you or somebody you know was injured by a contaminated medicine made by a compounding pharmacy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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