FDA Investigating Compounding Pharmacies Following Recall of Moldy Drugs
While many consumers worry about contaminated or moldy food, the notion that drugs may be contaminated by mold is not something most consumers suspect. However, the Food and Drug Administration (FDA) has issued a nationwide recall of all drugs sold by a “compounding pharmacy” in New Jersey because the medications may be contaminated by mold according to an AP report.
The drugs subject to the recall include a wide range of Med Prep Consulting Inc. drugs, which include a range of pain relief medications and antibiotics that are routinely used in surgical procedures.
This is the second recent recall issued by the FDA involving a compound pharmacy, which has triggered an FDA decision to step up inspections of compounding pharmacies in a dozen states that ship drug products throughout the U.S. Compound pharmacies mix formulations of drugs that correspond to custom specifications provided by a physician.
While the recently announced recall was linked to the discovery of mold in five bags of magnesium sulfate that was dispensed to a hospital in Connecticut, there have been other problems linked to recent issues involving compound pharmacies. A steroid medication sold last year by a compound pharmacy in Massachusetts that was contaminated caused the death of fifty people and made another 720 people ill across the U.S. based on the AP report. Many of those affected suffered a rare type of meningitis linked to a fungus discovered in the New England Compounding Center’s physical plant.
Although the AP report indicates that no injuries have been reported from the moldy Med Prep drug products, there have been reports involving patients suffering infection so the FDA indicated it was necessary to issue the recall because of the lack of assurances of sterility.
Drug companies and compounding pharmacies may be liable for defective pharmaceutical products that are unsafe in their design or that are manufactured in such a manner that contamination causes injury to consumers. Compound pharmacies and drug manufacturers have a legal obligation not to sell drugs that have been compromised by mold, bacteria or other substances that compromise the safety of the drug. Drug companies also have a legal obligation to provide adequate labeling that warns of risks associated with use of their pharmaceutical products. When pharmaceutical companies do not provide adequate warnings, they may be liable for such a failure.
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