Presence Of Rust Raises Sterility Concerns And Leads To Another Compounding Pharmacy Recall
By Kevin Duffan, VA/NC Medical Malpractice Attorney
The Food and Drug Administration has announced yet another recall by a compounding pharmacy, this time one based in St. Petersburg, Florida. The FDA has been on a tear recently, recalling products from multiple compounding pharmacies across the country in only the last several weeks. The streak of recalls is the result of a recent enforcement push by the agency to crack down on compounding pharmacies that have existed for far too long under lax state regulation.
The most recent recall involves the Compounding Shop which has agreed to recall all of its sterile drugs after a recent inspection by federal regulators revealed troubling problems with the safety of its drugs. Inspectors say they discovered “exposed rust” on equipment used to manufacture the supposedly sterile products. Beyond that, FDA officials say the report documents instances of “splattered brownish stains” on other surfaces in the manufacturing facility where the medications were mixed.
The presence of the contaminations raised concerns in the FDA that the drugs might be dangerous to consumers. Specifically, the FDA said that there were concerns about the safety of some injectable drugs and eye medications created by the Compounding Shop. The FDA’s Director of the Center for Drug Evaluation and Research was quoted as saying that if injectable drugs that are meant to be sterile are found to be contaminated, it could result in a life-threatening infection for unsuspecting patients. Though no reports of sick patients have been connected to the Compounding Shop, inspectors say a lack of sterility assurance is enough to justify a total recall of all their products.
The recall comes on the heels of a recent announcement by the national board of pharmacies which said the group would support efforts by Congress to allow the FDA to have increased power over compounding pharmacies. Until recently, the specialty companies were governed by state pharmacy boards and not often subjected to the strict regulations issued by the FDA. In the wake of the deadly fungal meningitis outbreak lawmakers have proposed doing away with this more relaxed arrangement and granting the FDA increased powers.
As experienced Virginia dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries.
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