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Doctor’s Best Issues Voluntary Nationwide Recall of Red Yeast Rice due to Undeclared Lovastatin

Contact:
Consumer:
1-844-717-0190

FOR IMMEDIATE RELEASE - June 24, 2014 - Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug. 

Consumers who use supplements found to contain lovastatin in rare cases could result in serious muscle injury; particularly if taking with prescription “statins” such as lovastatin, simvastatin, or atorvastatin. Pregnant women could theoretically put their unborn child at risk by using this product with undeclared lovastatin. Patients with pre-existing liver disease may be at an increase risk for liver injury following chronic use of statins. 

Doctor’s Best has not received any reports of adverse events related to this recall. Red Yeast Rice is used as a dietary supplement for lowering cholesterol and is packaged in white plastic bottle with orange flip-top lid, and clear tamper evident outer seal number of units, UPC code 753950001183. Red Yeast Rice product includes the following lot 3121005 and expires February 2017. 

Red Yeast Rice was distributed nationwide through retail and internet outlets. Doctor’s Best is notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have Red Yeast Rice which is being recalled should discontinue usage and return the unused portion to their place of purchase. 

Consumers with questions regarding this recall can contact Doctor’s Best at 1-844-717-0190 Monday through Friday 9am to 5pm PDT and contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.


This recall is voluntary and is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Photo: Product Labels

Some background about red yeast rice cited from wikipedia

Red yeast rice and drugs

In the late 1970s, researchers in the United States and Japan were isolating lovastatin from Aspergillus and monacolins fromMonascus, respectively, the latter being the same fungus used to make red yeast rice but cultured under carefully controlled conditions. Chemical analysis soon showed that lovastatin and monacolin K are identical. The article "The origin of statins" summarizes how the two isolations, documentations and patent applications were just months apart.[5] Lovastatin became the patented, prescription drug Mevacor for Merck & Co. Red yeast rice went on to become a contentious non-prescription dietary supplement in the United States and other countries.

Lovastatin and other prescription "statin" drugs inhibit cholesterol synthesis by blocking action of the enzyme HMG-CoA reductase. As a consequence, circulating total cholesterol and LDL-cholesterol are lowered. In a meta-analysis of 91 randomized clinical trialsof ≥12 weeks duration, totaling 68,485 participants, LDL-cholesterol was lowered by 24-49% depending on the statin.[6] Different strains of Monascus fungus will produce different amounts of monacolins. The 'Went' strain of Monascus purpureus (purpureus = dark red in Latin), when properly fermented and processed, will yield a dried red yeast rice powder that is approximately 0.4% monacolins, of which roughly half will be monacolin K (identical to lovastatin). Monacolin content of a red yeast rice product is described in a 2008 clinical trial report.[7]

Regulatory restrictions

The Food and Drug Administration (FDA) position is that red yeast rice products that contain monacolin K, i.e., lovastatin, are identical to a drug and, thus, subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. District Court in Utah allowed the product to be sold without restriction. This decision was reversed on appeal to the U.S. Court of Appeals. (Moore, 2001) (see Further Reading: PDRhealth). Shortly thereafter, the FDA sent Warning Letters to companies selling red yeast rice. The product disappeared from the market for a few years.

In 2003, red yeast rice products began to reappear in the U.S. market. As of 2010, there are at least 30 brands available. Many of these avoid the FDA restriction by not having any appreciable monacolin content. Their labels and websites say no more than "fermented according to traditional Asian methods" or "similar to that used in culinary applications." The labeling on these products often says nothing about cholesterol. If they do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol, they are not subject to FDA action. Two reviews confirm that the monacolin content of red yeast rice dietary supplements can vary over a wide range, with some containing negligible monacolins.[8][9] In 2007, the FDA sent Warning Letters to two dietary supplement companies. One was making a monacolin content claim about its RYR product and the other was not, but the FDA noted that both products contained monacolins. Both products were withdrawn.[10][11] The FDA also issued a warning press release (see Further Reading; FDA 2007). The crux of the release was that consumers should "…not buy or eat red yeast rice products…may contain an unauthorized drug that could be harmful to health." The rationale for "…harmful to health…" was that consumers might not understand that the dangers of monacolin-containing red yeast rice might be the same as those of prescription statin drugs.