The Food and Drug Administration (FDA) last month advised healthcare providers to remove all products from a drug supplier due to improper labeling.
The FDA warned healthcare providers in April that drugs distributed by Shamrock Medical Solutions may be mislabeled and therefore should not be administered to patients. In its warning letter, the FDA wrote, “”This notice covers all drugs and dosage forms distributed by Shamrock including tablets, vials, ophthalmic and otic solutions and patches.”
Shamrock Medical Solutions out of Lewis Center, Ohio, is the leading provider of pharmaceutical unit dose repackaging services to the health care industry, and provides, according to the company’s webpage, over two hundred hospitals, pharmacies and medical centers across the country repackaged and relabeled drugs.
Although the company’s online site reports it repackages all drugs following USP and FDA guidelines and follows current Good Manufacturing Practices, the company has been warned in the past, once in 2010 and again in 2012, by the FDA for violations linked to the mislabeling of pharmaceutical drugs and is currently under fire for the same violations.
In its latest inspection, the FDA found that Shamrock had been distributing drugs with incorrect labels, labels that included: a different drug than what was included in the container; a drug with the wrong dose strength; and a drug not identified as extended release. These mislabeled drugs, of course, pose serious risks to patients.
“Patients may receive a drug that causes harm resulting in unintended effects. The potential risks include overdose, dangerous drug interactions, and unnecessary exposure to toxicity and side effects. Most importantly, patients would not receive the therapeutic benefits from the drug they need to take. In addition, patients may experience the side effects of a drug they do not need,” the FDA said.