Actavis Group’s U.S. division, Actavis Totowa LLC, has recalled all lots of heart failure treatment Digitek (digoxin tablets). The company announced the Class I nationwide recall for Digitek after the possible commercial release of tablets with twice the approved level of the active ingredient, posing a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

Herbal Science International Inc is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and cause stress to the circulatory system, effects that are linked to adverse health conditions such as heart attacks and strokes.

Johnson & Johnson’s PriCara unit has voluntarily recalled all lots of 25-microgram-per-hour Duragesic CII pain patches that have an expiration date of on or before December 2009. The recall is due to a possible cut in the lining of the internal reservoir that could cause the gel to leak. Direct exposure to the fentanyl drug can cause serious events, such as breathing problems, or even a potentially fatal overdose.

Chattem Inc. has voluntarily recalled its Icy Hot Heat Therapy products, following reports of skin irritation and first, second and third degree burns. The recalled products include Icy Hot Heat Therapy Air Activated Heat – Back, Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg and Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg single consumer use (samples). Company spokesperson Catherine Baker said, “Because we are unsure if it is misuse or not, we’re going to study that before we make the decision to put the product back on the market or not.”