Recalls of Products Intended for Health, page 4

Product Recalls

Fri, 27 Aug 2010

Cal-Maine Foods, Inc. Clarifies Previous Statement on Nationwide Shell Egg Recall

Cal-Maine Foods, Inc. (NASDAQ: CALM) today issued the following clarification regarding the previously announced voluntary recall of shell eggs supplied from Hillandale Farms of Iowa. This information does not increase the total number of eggs which Cal-Maine purchased from Hillandale Farms, which was previously announced on August 20, 2010. Cal-Maine immediately contacted its customers to ensure that any eggs included in the recall were withdrawn from the marketplace.

http://www.fda.gov/Safety/Recalls/ucm224199.htm

Wed, 15 Sep 2010

Westmed, Inc. Issues Nationwide Recall of BagEasy Manual Resuscitation Devices

Westmed, Inc., Tucson, AZ, is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The select lots listed below of the BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold.

http://www.fda.gov/Safety/Recalls/ucm225844.htm

Wed, 15 Sep 2010

Kilosports Inc. Issues Voluntary Recall of Clomed

KiloSports Inc. of Phoenix, AZ is recalling 60 Count bottles of Clomed because it may contain an Aromatase Inhibitor. KiloSports Inc. has been informed by the US Food and Drug Administration (FDA) that adverse events associated with the use of Aromatase Inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.
Consumers who have purchased Clomed are asked to return it to the place of purchase for a full refund. Consumers with any questions may contact the company at 1.480.545.3489 9AM – 5PM Monday – Friday.

http://www.fda.gov/Safety/Recalls/ucm225847.htm

Thu, 16 Sep 2010

G.E.T. Issues Vouluntary Recall of ArimaDex

Genetic Edge Technologies of Phoenix, Arizona is voluntarily recalling 60 count bottles of ArimaDex, because it may contain an Aromatase Inhibitor. Genetic Edge Technologies has been informed by the US Food and Drug Administration (FDA) that potential adverse events associated with the use of Aromatase Inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.

Consumers who have purchased ArimaDex are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-480-248-7957 during the hours of 9AM – 2PM M-F.

http://www.fda.gov/Safety/Recalls/ucm225848.htm

Thu, 16 Sep 2010

Advanced Muscle Science Issues a Voluntary Nationwide Recall of AROM-X Capsules, AROM-X UTT Liquid, AROM-XL Liquid, 4-AD Capsules and Decavol Capsules Marketed as a Dietary Supplements Containing ATD

Advanced Muscle Science, 4590 Deodar St., Silver Springs, Nevada 89429, announced today that it is conducting a voluntary nationwide recall of all Lot Codes of the company’s dietary supplement products sold under the names Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol, which are marketed as Natural Testosterone Boosters and Libido Enhancers. The products contain 1,4,6 etioallocholan-dione, also known as ATD, an aromatase inhibitor. These products are sold both individually and as part of promotional “Kits”.

The Company is advising consumers who have Arom-X Capsules, Arom-X UTT Liquid, Arom-XL Liquid, 4-AD Capsules and Decavol Capsules to return any unused portion to the retail location from which it was purchased or if purchased directly from Advanced Muscle Science to return any unused portion to: Fitness Connection c/o AMS Fulfillment, 350 Faunce Corner Road, North Dartmouth, MA 02747; (800) 854-3891.

http://www.fda.gov/Safety/Recalls/ucm226145.htm

Thu, 16 Sep 2010

The MedWatch August 2010 Drug Safety Labeling Changes includes 24 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The following drugs had new or modified safety information in the CONTRAINDICATIONS and WARNINGS sections:

  • Advil Allergy Sinus (ibuprofen, chlorpheniramine maleate, and pseudoephedrine)
  • Aleve (naproxen sodium)
  • Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
  • Biltricide (praziquantel)
  • Childrens Advil Cold (ibuprofen and pseudoephedrine)
  • Cubicin (daptomycin)
  • Exelon Patch (rivastigmine)
  • Flagyl (metronidazole)
  • Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection
  • Meridia (sibutramine hydrochloride)
  • Plavix (clopidogrel bisulfate)
  • Risperdal (risperidone)

The “Summary Page” provides a listing of drug names and safety labeling sections that have been revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225299.htm


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