FDA MedWatch

A power supply assembly failure can result in the inability to deliver defibrillation therapy.

Drug failed to demonstrate clinical benefit to patients enrolled in trials.

Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.

Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.

Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant.

FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.

Injectable products may contain particulate matter.

AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.

[UPDATED 06/08/2010] Recall classified as Class I. Various sizes of counterfeit flat sheets of polypropylene surgical mesh marketed in the U.S. labeled with the C. R. Bard/Davol brand name.

Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.

[UPDATED 06/03/2010] Drug labels now contain updated recommendations.

The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices. Posted 05/30/2010

Products sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product.

Product contains substances which are poisonous when ingested or applied to large areas of the body.

Voluntary recall of all manufactured lots has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing.

Revised labeling to include cases of severe liver injury.

Possible increased risk of fractures of the hip, wrist, and spine.

Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.