FDA Recalls Two SupplementsNov 26, 2008 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) has issued two immediately effective recalls involving potentially dangerous nutritional supplements. Both recalls have been implemented over undeclared, prescription-level ingredients, which classifies them as unapproved drugs.
In the first recall, Balanced Health Products, Inc. is voluntarily recalling Starcaps Dietary Supplement Capsules because they were found to contain an undeclared drug ingredient: Bumetanide at a level of 0.8 mg per capsule. The lot number involved is 12/2011–84810 and the supplements were sold in 30-capsule plastic bottles. The bottles—1,974 in total—were distributed nationwide from August 2008 to October 30, 2008 to retail outlets and via online sales.
The FDA notes that bumetanide is a prescription diuretic that is not listed as an ingredient on the Starcaps Dietary Supplement Capsules’ product label and is indicated for edema associated with congestive heart failure and hepatic and renal disease, including nephrotic syndrome. Bumetanide risks include serious and significant fluid and electrolyte loss as well as uric acid concentration elevations.
Those with sulfonamide—a type of sulfa antibiotics—allergies are warned against taking Bumetanide. Also, significant drug interactions and an increased risk of toxicity can occur in those taking digoxin and lithium with bumetanide as well as an increased risk of hypotension/low blood pressure, fainting/syncope. There is also concern that people with normal blood pressure or who are taking anti-hypertensive medications who take the Starcaps Dietary Supplement Capsules with undeclared bumetanide may also suffer from “resultant” injury.
The FDA is advising consumers to immediately discontinue use of the recalled Starcaps Dietary Supplement Capsules and returned the recalled products to Balanced Health Products, Inc. at the address on the recalled product’s label. The firm can be reached at (212) 794-9793 from 10:30 am to 4:00 pm EST Monday through Friday.
In the second recall, the FDA announced that Fashion Sanctuary has issued a voluntary nationwide recall of all lots of its Zhen De Shou Fat Loss Capsules because they contain an undeclared ingredient: Sibutramine, an FDA-approved medication used as an appetite suppressant for weight loss. Zhen De Shou Fat Loss Capsules are sold in 10-count blister cards. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Fashion Sanctuary’s Shen De Shou Fat Loss Capsules were mostly distributed nationwide in the United States and sold via the Internet in a box with an inner foil pouch. The blister pack is contained within the pouch; the capsules are light and dark green. The recall affects all lot codes and Use By dates.
Consumers are advised to immediately discontinue using the recalled Fashion Sanctuary Shen De Shou Fat Loss Capsules and contact the firm at email@example.com for additional information and return instructions.