Huntsville Personal Injury Lawyer - recall

Follow-Up to Hydroxycut Recall

Margaret Embry — Mon, 18 May 2009 09:41:44 GMT

As a follow-up to the May 1, 2009 Hydroxycut recall post, the FDA has released more information about the recall. As of May 7, 2009,

Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

These additional UPC numbers being added to the May 1st list include:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets

Iovate initiated this voluntary recall after the FDA reported that 23 consumers had experienced liver-related problems, which is different from Iovate's analysis.

Consumers with questions about the recall can visit www.hydroxycutinformation.com for more information. Consumers can also contact the company by calling 1-877-468-2835 Monday through Friday between 9 am and 5 pm Eastern Daylight Time.

Originally posted at InjuryBoard by Margaret Embry

The FDA Warns Consumers to Stop Using Hydroxycut Products

Tara Helms — Fri, 01 May 2009 13:21:14 GMT

The FDA is warning consumers to immediately stop using Hydroxycut products. Some Hydroxycut products are associated with a number of serious liver injuries. The manufacturer, Lovate Health Sciences Inc. of Oakville, Ontario has agreed to recall Hydroxycut from the market. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

The FDA has received numerous reports of serious health problems ranging from jaundice and elevated liver enzymes to liver damage requiring liver transplant. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis (a type of muscle damage that can lead to other serious health problems such as kidney failure). The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

The list of products being recalled by Lovate currently includes:

Hydroxycut Regular Rapid Release Caplets

Hydroxycut Caffeine-Free Rapid Release Caplets

Hydroxycut Hardcore Liquid Caplets

Hydroxycut Max Liquid Caplets

Hydroxycut Regular Drink Packets

Hydroxycut Caffeine-Free Drink Packets

Hydroxycut Hardcore Drink Packets (Ignition Stix)

Hydroxycut Max Drink Packets

Hydroxycut Liquid Shots

Hydroxycut Hardcore RTDs (Ready-to-Drink)

Hydroxycut Max Aqua Shed

Hydroxycut 24

Hydroxycut Carb Control

Hydroxycut Natural

Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax (800-FDA-0178) or phone (800-FDA-1088).

Originally posted at InjuryBoard by Tara Helms

Urgent Drug Recall -- Digitek

Tara Helms — Fri, 23 May 2008 16:02:40 GMT

People are receiving phone calls and pharmacy letters notifying them that their heart drug may be unsafe.

Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a nationwide recall of Digitek (digoxin tablets, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. All lots of the drug Digitek, a generic form of digoxin, are being removed from shelves.

The voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredients than is appropriate.

Digitek is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

This recall is being conducted with the knowledge of the Food and Drug Administration. Given the risk of serious injury or death associated with the use of the recalled drug, pharmacists have been asked to directly contact customers. Many pharmacies are reaching out to any individual who had a prescription filled within the past 12 months.

Originally posted at InjuryBoard by Tara Helms