FDA MedWatch

Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death.

Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death.

Use of contaminated products may lead to bacterial infection of the blood.

Potential for product breakdown and loss of potency if not dispensed and stored in the original bottle or blister package.

Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Use of recalled product can result in elevated blood glucose levels (hyperglycemia), which can lead to serious health complications including death.

Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.

Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections which could be fatal, especially in patients who are immunocompromised.

Bottles labeled as citalopram may contain finasteride.

Product marketed as dietary supplement contains terazosin, adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope.

UPDATED 03/23/2011. Eli Lilly notified customers not to use Prep Pads in black starter kits for Forteo [teriparatide (rDNA origin) injection]. Use of contaminated alcohol prep pads, alcohol swabs or alcohol swabsticks could lead to life-threatening infections.

Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients.

UPDATED 03/18/2011. Dexamethasone Sodium Phosphate Injection products recalled.

Possible false-negative results may occur. This may cause serious adverse consequences and/or death.

Product marketed as dietary supplement contains Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

New Warning about serious heart, kidney, or breathing problems which can be fatal.

Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy.

Endotoxins in product can cause serious illness, at times fatal.