Undeclared High Cholesterol Drug Leads to Drug Recall for Red Yeast Rice Dietary Supplement

Supplement manufacturer Doctor’s Best has issued a voluntary drug recall for their Red Yeast Rice Dietary supplement due to undeclared cholesterol medication. The dietary supplement was found to have undeclared lovastatin, a generic drug used to treat high cholesterol, but which can have serious side effects with long-term use. In rare cases of long-term or high dose use, lovastatin can cause serious muscle injury. The risk of muscle injury is especially high when lovastatin is mixed with other cholesterol or statin medications, including simvastatin or atorvastatin.

Pregnant women might also be putting their unborn children at risk of developmental disorders if they take lovastatin, and patients with pre-existing liver disease could be at greater risk of liver problems or failure due to chronic use of statins.

Doctor’s Best said they have not received any reports of illness or injury related to the undeclared drug that led to their drug recall. The supplement under drug recall, Red Yeast Rice dietary supplement, comes in a white plastic bottle with an orange flip-top lid.

The lot under drug recall is 3121005, and expires in February 2017. The UPC number is 753950001183. Doctor’s Best said they would notify their national distributors and mail/online customers about the drug recall.

The FDA and Failure to Regulate Dangerous Drug Recalls

Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls ”grossly underestimates the number of products on sale with unapproved ingredients.” “Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.

A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements.

For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011. In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra. Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals.

Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.

The Strom Law Firm Can Help with Dangerous Drug Recall Cases

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800