FDA Announces Recall of Drugs Produced by Abrams Royal Compounding
In the wake of a meningitis outbreak last year, the sale of contaminated drugs continues to be a nationwide health problem.
Earlier we discussed the Drug Quality and Security Act, a recently enacted statute intended to give the Food and Drug Administration (FDA) oversight of compounding facilities. The act gives the FDA some authority to protect healthcare providers and consumers from contaminated pharmaceutical products.
In late December, the FDA announced a voluntary recall of all nonexpired products produced by Abrams Royal Compounding Pharmacy of Dallas, Texas. The recall comes after a California patient who received Abrams products fell ill and tested positive for infection by Stenotrophomonas maltophilia, a bacteria spread largely through contaminated hospital devices and fluids.
A healthy immune system can combat infection by Stenotrophomonas maltophilia, but the bacteria cause infection when they are able to bypass the body’s normal defense mechanisms. Once established, the bacteria can cause:
- Other infections
The Abrams products in question were sold between June 2013 and Dec. 17, 2013. The patient sickened by contamination had been treated with a mineral intravenous injection. In addition to IV medications, other possibly dangerous Abrams products include:
- Eye drops
- Nasal sprays
- Pellet implants
- Inhalation solutions
The Drug Quality and Security Act phases in over the coming years. Until it’s fully in effect, problems and injuries caused by compounded drugs produced in nonsterile environments are likely to persist. If you have been injured though a medication mistake or a contaminated pharmaceutical product in North Carolina, talk with a skilled injury attorney.