FDA issues warning over Man Up Now capsules
SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.
The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Even though they are marketed as supplements, the inclusion of any prescription medicines would redefine these products as adulterated drugs. The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra.
Man Up Now, distributed by Synergy Distribution, is sold on Internet sites, online marketplaces, and possibly in retail outlets in single, double and triple blister packs, and in 6-, 12- and 30-count capsule bottles, the FDA reported.
NACDS offers FSA resources to members
ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Friday released a ready-made pamphlet and sign for its retail members to use in communicating upcoming flexible spending account changes as they relate to over-the-counter medicines.
“As part of the healthcare-reform law, beginning Jan. 1, 2011, consumers will only be eligible for flexible spending account reimbursement for over-the-counter medication purchases obtained with a prescription,” the association stated. “This change will have a real and dramatic impact on companies and consumers as more than 15,000 products will be impacted. NACDS has been working to repeal or delay certain provisions of the OTC regulations to provide more time for chain companies to update their systems to better serve customers.”
To access the new member resources, go to NACDS.org/wmspage.cfm?parm1=7016.
McNeil issues voluntary recall of Rolaids products
FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday voluntarily recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multisymptom Plus Antigas Softchews distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles.
The company’s investigation has determined that the materials potentially were introduced into the product during the manufacturing process at a third-party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advised consumers who have purchased these recalled products to discontinue use.
“While our investigation is ongoing, we have suspended production [of these products] and will not restart production until corrective actions have been implemented,” the company stated.