Undeclared and Banned Pharmaceuticals Lead to Supplement Recalls from Two Manufacturers

Two dietary supplement manufacturers have issued supplement recalls after the FDA found undeclared pharmaceuticals in the products.

REFA Enterprises, which manufacturers Forever Beautiful Bee Pollen, has issued a voluntary supplement recall for one lot of their product at the consumer level, due to undeclared Sibutramine, or a combination of Sibutramine and Phenolphthalein. The pharmaceuticals were found during a routine FDA lab analysis of the supplements. Subitramine is an appetite suppressant pharmaceutical which was banned in the US in October 2010 because it could lead to an increased risk of seizures, strokes, heart attacks, and arrhythmia. Phenolphthalein is a drug used in many laxatives, but has not been approved for sale in the US due to concerns about an increased risk of cancer. Both of the pharmaceuticals can interact with other prescription drugs the supplement user is already taking and increase the risk of numerous side effects and health risks.

REFA Enterprises says it has voluntarily issued the supplement recall, and has not received any reports of adverse events related to the Bee Pollen weight loss supplement.

Another supplement recall comes from Chaotic Labz, based in Atkins, Arkansas. The company has issued a nationwide supplement recall for Mayhem dietary supplement capsules, with an expiration date of 06/2016, at the consumer level. The supplement was designed as an “all natural” bodybuilding supplement, but FDA laboratory analysis found two undeclared pharmaceuticals – dexamethasone and cyproheptadine.

Dexamethasone is a corticosteroid used to treat inflammatory conditions like chronic allergies, and cyproheptadine is a prescription antihistamine used for seasonal allergy treatment. While both of these drugs have been approved for sale in the US by the FDA, they have not been approved for use in the supplement, leading to the supplement recall.

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.

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.

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