FDA MedWatch Safety Alerts
Updated: 2 hours 23 min ago
Fri, 07/02/2010 - 19:15
The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.
Fri, 07/02/2010 - 12:15
A power supply assembly failure can result in the inability to deliver defibrillation therapy.
Mon, 06/21/2010 - 14:20
Drug failed to demonstrate clinical benefit to patients enrolled in trials.
Mon, 06/21/2010 - 07:30
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.
Thu, 06/17/2010 - 15:00
Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.
Tue, 06/15/2010 - 11:00
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.
Fri, 06/11/2010 - 10:00
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.
Thu, 06/10/2010 - 08:30
Injectable products may contain particulate matter.
Wed, 06/09/2010 - 10:25
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.
Tue, 06/08/2010 - 14:10
[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.
Fri, 06/04/2010 - 15:30
Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.
Thu, 06/03/2010 - 12:44
[UPDATED 06/03/2010] Drug labels now contain updated recommendations.
Fri, 05/28/2010 - 23:00
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.
Fri, 05/28/2010 - 23:00
The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices. Posted 05/30/2010
Fri, 05/28/2010 - 08:56
Product contains substances which are poisonous when ingested or applied to large areas of the body.
Wed, 05/26/2010 - 15:25
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.
Wed, 05/26/2010 - 10:00
Revised labeling to include cases of severe liver injury.
Tue, 05/25/2010 - 14:00
Possible increased risk of fractures of the hip, wrist, and spine.
Tue, 05/25/2010 - 09:28
Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.