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FDA MedWatch Safety Alerts
Updated: 2 hours 23 min ago

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall

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.

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

Fri, 07/02/2010 - 12:15
A power supply assembly failure can result in the inability to deliver defibrillation therapy.

Mylotarg (gemtuzumab ozogamicin): Market Withdrawal

Mon, 06/21/2010 - 14:20
Drug failed to demonstrate clinical benefit to patients enrolled in trials.

Magic Power Coffee: Undeclared Drug Ingredient

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.

Tamiflu: Counterfeit Product Sold on Internet

Thu, 06/17/2010 - 15:00
Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.

Vitamin D Supplement Products: Medication Use Error

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.

Benicar (olmesartan): Ongoing Safety Review

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.

Hospira Brand Liposyn and Propofol: Recall

Thu, 06/10/2010 - 08:30
Injectable products may contain particulate matter.

Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall

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.

Counterfeit Polypropylene Surgical Mesh: Initial Communication

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.

GammaGard Liquid, Immune Globulin Intravenous (Human)

Fri, 06/04/2010 - 15:30
Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

Thu, 06/03/2010 - 12:44
[UPDATED 06/03/2010] Drug labels now contain updated recommendations.

Intravenous Medications Manufactured by Claris: Recall due to contamination of products

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.

PediaCare Children's Products [Blacksmith Brand]: Recall of four products

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

Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic

Fri, 05/28/2010 - 08:56
Product contains substances which are poisonous when ingested or applied to large areas of the body.

Hylenex recombinant (hyaluronidase human injection): Recall

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.

Orlistat (marketed as Alli and Xenical): Labeling Change

Wed, 05/26/2010 - 10:00
Revised labeling to include cases of severe liver injury.

Proton Pump Inhibitors (PPI): Class Labeling Change

Tue, 05/25/2010 - 14:00
Possible increased risk of fractures of the hip, wrist, and spine.

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Tue, 05/25/2010 - 09:28
Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.