Nova Products Issues Drug Recall for Supplement Due to Undeclared Pharmaceuticals
The supplements under drug recall are African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012), at the retail level.
According to the FDA, laboratory analysis of the supplements determined that they contained undeclared amounts of two drugs, sildenafil and tadalafil, which are FDA-approved drugs used to treat erectile dysfunction.
The drug recall was issued because the undeclared drugs can react with the nitrates in other prescription medications, especially heart medications, which can lead to decreased blood pressure. The undeclared drugs can, additionally, cause consumers side effects like headaches and flushing.
As part of the drug recall, Nova Products has discontinued distribution and sales of the sexual enhancement supplements. The company recommends that consumers immediately stop using the supplements and return the product to Nova Products in Pennsylvania for a refund.
Consumers with questions regarding this recall can contact Nova Products, Inc. by telephone at 610-459-7709 between 9:00 a.m. and 5:00 p.m. EST.
Although no reports of injury or side effects have been reported to the FDA related to the supplement, both the FDA and Nova Products recommend that consumers who experience side effects after taking the supplement should immediately consult their doctor.
New Research Shows Unapproved Ingredients in Dietary Supplements Cause Half of Dangerous Drug Recalls
US researchers have found that dietary supplements, which often contain unapproved or unlisted ingredients, make up just over half of all dangerous drug recalls in the United States.
Most of the dangerous drug recalls were issued for supplements that claimed to boost sexual performance, build muscle, or aid weight loss. “Supplements” are allowed to contain vitamins, minerals, and herbs, but they are not allowed to contain pharmaceuticals.
The study called for much more stringent guidelines to regulate dietary supplements. Currently, the market has very little FDA oversight. Federal law does not require that supplements – which are supposedly herbal rather than pharmaceutical – go through the FDA for approval before they can be packaged and sold.
However, because of the lack of oversight, supplements containing pharmaceutical compounds have entered the market.
Harel and colleagues used data collected by the FDA about Class I recalls from between January 1, 2004, to December 19, 2012. Of the 465 recalled drugs, 237 were dietary supplements. Nine out of ten of the supplement recalls occurred after 2008. All of the dangerous drug recalls were issued due to unapproved pharmaceutical ingredients. An additional 110 supplements were known to contain unapproved pharmaceuticals, but were not recalled.
About 24% of the recalled supplements were manufactured outside the US. The study noted this is a concern, as other countries do not adhere to the same manufacturing practices. In the US, supplement manufacturers are expected to adhere to current good manufacturing practices (CGMP) as defined by federal regulations. However, the study also noted that at least half the supplements manufactured in the US violated CGMP.
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 dangerous drugs, tainted dietary supplements, or medical devices that did not receive a proper drug recall, 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