RegenArouse: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumer

ISSUE: Regeneca, Inc. notifed the public of a nationwide recall of RegenArouse, Lot Number 130100. FDA lab analysis confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product an unapproved new drug.

Use of this product may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these...

AUDIENCE: Consumer

ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of "Koff & Kold" spray with herbal extract and "Kold Sore" spray with liquid sea mineral. "Koff & Kold" spray with herbal extract is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. "Kold Sore" spray with liquid sea mineral is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. The product is also intended to be sprayed into the nose for sinus allergy by pollen, and onto the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.

These products are not...

Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective

AUDIENCE: Dentistry

ISSUE: FDA notified healthcare professionals, including dentists, dental care professionals and veterinarians, about the illegal sale of hand-held dental X-ray units that have not been reviewed by the FDA. The FDA is aware of hand-held dental X-ray units being sold online by manufacturers outside the U.S. and directly shipped to customers in the U.S. These devices may not be safe or effective and could potentially expose the user and the patient to unnecessary and potentially harmful X-rays.

BACKGROUND: All hand-held dental X-ray units that have been certified by...

Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions

AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir...

Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs

• AcipHex (rabeprazole sodium)
• Dexilant (dexlansoprazole)
• Nexium (esomeprazole magnesium) 
• Omeprazole (omeprazole) Over-the-Counter (OTC)
• Prevacid (lansoprazole) and OTC Prevacid 24hr
• Prilosec (omeprazole)  and OTC
• Protonix (pantoprazole sodium)
• Vimovo (esomeprazole magnesium and naproxen)
• Zegerid (omeprazole and Sodium bicarbonate) and OTC

AUDIENCE: Gastroenerology, Family Practice, Consumer

ISSUE: FDA notified the public that the use of stomach acid...

Recall includes the following products/lot numbers/UPC numbers:

• Mince Belle Dietary Supplement (30 Capsules) Lots HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021; UPC7503013203305
• PERFECT Men Dietary Supplement (30 Capsules) Lots HPCPM/002; UPC7503013203190
• EVERLAX Dietary Supplement (30 Capsules) Lots HPCEX/074, HPCEX/076, HPCEX/072; UPC7503013203046
• EVER Slim Dietary Supplement (30 Capsules) Lots HPCES-079, HPCES-070, HPCES-071; UPC7503013203053
• Herbal Drink Acai-man Mangosteen Dietary Supplement (16.6 fl oz) Lots HPJAC/004 : UPC7503013203015
• EVER SLIM Shake Mix Dietary Supplement Strawberry (17.6 oz) Lots HPESSF/168: UPC7503013203084
• EVER SLIM Shake...

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up

AUDIENCE: Consumer

ISSUE: Pedinol Pharmacal Inc. notified healthcare professionals, pharmacists and patients of a potential problem with Gris-PEG (griseofulvin ultramicrosize) 125mg and 250mg manufactured and packaged by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.

BACKGROUND: Gris-PEG (griseofulvin ultramicrosize) is...