The Abrams Royal Compounding Pharmacy that has issued the contaminated drug recall is located in a small, generic “strip mall” setting near a fine veterinarian, a Walgreen’s, a dry cleaner, and various other establishments at the intersection of Abrams and Royal in Dallas. The compounding pharmacy seems to have a rather prominent sign for such a venue.
What do Compounding Pharmacies do?
The Houston drug recall attorneys at Denena Points, PC mention that the real purpose of compounding pharmacies, and the reason why they were allowed exceptions under the FDA oversight system, was because they originally only filled individual prescriptions for individual patients with special needs. For instance, if a patient was allergic to a specific ingredient in a “brand” medication, the compounder could mix the drug with alternative ingredients. Or if the patient was a child and couldn’t tolerate taking the medication in its natural, medicinal flavor, a cherry or other flavoring could be added to make it more palatable. Or if a patient needed a smaller or larger dosage because of their weight or some other factor, the compounder could mix the medication to suit.
Compounding Pharmacies have a Difficult Time Maintaining Sterile Production Practices when they Mass-Produce their Products
In recent years plagued by huge medication recalls and unusual numbers of patients wanting additional medications, compounding pharmacies have matured into mass production roles. And the pressures of mass production have often left the pharmacies behind the curve on facility sterility and oversight procedures.
Such was the case with the New England Compounding Center (NECC) that produced a (so-called) sterile, injectable pain medication commonly used for back pain patients. The medication became contaminated with mold and fungus due to un-sterile production techniques and facilities and was distributed all over the nation. More than 700 patients became ill and infected, and at least 50 patients died from the fungal meningitis contracted from the contaminated medication in the fall of 2012.
Since that time, the FDA has been taking a closer look at compounding pharmacies and conducting more facilities inspections. In spite of stepped-up enforcement, the pressures of the industry, with lots of money to be made in mass production and few threats of penalties for negligent practices, have led to continuing lots of contaminated medication from contaminated facilities that seem to have little regard for sterile practices or production methods.
The Danger when Sterile Medications aren’t Sterile
Our Houston drug recall attorneys emphasize that many of the compounding pharmacies’ products are called sterile medications. That is, the medicines are supposed to be produced with the strictest regard for clean production methods and practices because often they get injected directly into the patients’ bloodstreams at sensitive sites in the body. Such was the case with the NECC pain medication that was injected into the body at the spine and led to hundred of serious illnesses, abscesses, and secondary infections, and to dozens of deaths.
About the Abrams Royal Compounding Pharmacy Recall
A patient in California has now suffered an adverse medical event, not specified in news accounts of the incident, after an injection of a so-called “sterile” mineral IV medication from the Abrams Royal Compounding Pharmacy in Dallas. The medicine’s lot number was 11142013@74. The California patient tested positive for Stenotrophomonas maltophilia, a bacterium that can lead to many serious infections including pneumonia, meningitis, and bloodstream infections.
The Abrams Royal Compounding Pharmacy has since issued a voluntary recall on all of its non-expired products and has advised patients and healthcare providers to stop using the medications. The recalled products include injectable medicines like IV injections, as well as eye drops, nasal sprays, pellet implants, and eye ointments distributed from 6/17/13 to 12/17/13. To return products or to get assistance related to the recall, people may call the compounding pharmacy at 214-349-8000. Patients affected by adverse events form the medication can report them to the FDA at www.fda.gov.medwatch/report.htm.
Contact the Houston Drug Recall Attorneys at Denena Points, PC if You need Experienced Legal Help with an Adverse Medical Event from a Compounding Pharmacy Product
Our experienced attorneys provide a free, initial legal consultation to discuss your injury or the injury of your family member and to evaluate your potential eligibility for a full financial recovery for the harm you’ve suffered. Call us at 713-807-9500 or reach us through our online contact form to schedule your free consultation.