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Recalled Products Include Health, Food, Hygiene Items

Recall-SidebarSeveral products were subjects of recalls by the U.S. Food and Drug Administration today, including health items, food and hygiene treatments.

HAIR TREATMENTS

Perfect Image Solutions, LLC is voluntarily recalling all lots of Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugs” under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.


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Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

Perfect Image Solutions, LLC has not received reports of serious injuries associated with the products subject to this voluntary recall.

These products are used to slow or stop hair loss and promote hair regrowth and are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units. They are used by men and women generally in middle to late adulthood. The affected product lots include the following lot numbers and expiration dates:

Product Name

Lots

Expiration

UPC Number

Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL.

All

Up until Oct. 2013

736211275813

Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL.

All

Up until Oct. 2013

736211276018

Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL.

All

Up until Sept. 2014

736211276117

Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL.

All

Up until Nov. 2013

736211274519

Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL.

All

Up until Dec. 2013

736211276414

The product can be identified by the name Perfect Image Solutions on the container. Product was distributed nationwide or worldwide via the internet.

Perfect Image Solutions, LLC is notifying its distributors by phone and in writing, and is arranging for return of all recalled products. Consumers that have product which is being recalled should discard it.

Consumers with questions regarding this voluntary recall can contact Perfect Image Solutions, LLC by phone number (916) 791-3230 or e-mail address dave@perfectimagesolutions.com, Monday–Friday from 9 AM–5 PM PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

HEALTH SOFTWARE

CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.

The company initiated the voluntary recall, which affects 125 devices and 58 software licenses, in October 2011. The devices and software subject to the recall were distributed to 38 customers between May 7, 2009 and July 11, 2011. This action has no effect on the manufacture or distribution of current products.

There is no change to the remediation plan previously communicated by the company. CareFusion has already completed the majority of the corrective actions on affected products in the United States.

In October 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. Affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the Cortical Stimulator Control Unit screen and in the associated report. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

In the notification letter, customers were provided serial and version numbers of affected hardware and software. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-nicoletone-software.aspx .

Instructions to customers Customer inquiries related to this action should be addressed to the CareFusion NeuroCare Call Center at 800-356-0007 (press option 2 for Technical Support).
3750 Torrey View Ct
San Diego, CA 92130
www.CareFusion.com

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.

 

SPONGE CAKE

Last week, Rich Products Corporation expanded its January 5, 2012 recall of ¼ Sheet Vanilla Soaked Sponge Cake Artificially Flavored to include the 8” Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored (Product Code: 62938) because of the possibility that small plastic fragments from the packaging were contaminating the product. Rich’s executed the expanded recall on January 12, 2012.

Rich Products Corporation has not received any customer complaints or reports of injuries related to this product, and has issued this voluntary recall as a precautionary measure.

The product is produced by Rich’s in Ocoyoacac, Mexico, and imported into the U.S. by Rich’s for sale. The UPC code is: 00049800629387. Product produced after July 10, 2011 is affected.

The 8” Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored is not packaged for retail distribution and is sold by the case primarily to in-store bakeries nationwide. On January 12, 2012, Rich’s notified all of its distributors and customers who have received the product in question, and directed them to remove and destroy the affected product. All other affected product under Rich’s control has been quarantined and will be destroyed.

Upon investigation, Rich’s discovered the problem was caused by a change in the resin used by the supplier of the plastic packaging. Rich’s was not made aware of this change. The company is working closely with the supplier to ensure that all defective packaging is removed from distribution and that all monitoring systems are in place to eliminate the potential for this problem occurring again in the future.

Consumers with questions may contact the Rich’s Product Helpline at 1-800-356-7094 (United States) between the hours of 8:30 a.m. and 5:00 p.m. EST. Voice mail is available after hours.

CHEESE

Kradjian Imp Co, Glendale, CA is recalling 231 Cases, 22Lb / Cs of Cedar Tree  brand Tresse Cheese, 16 oz and Cedar Tree brand Shinglish cheese, 16 oz because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Tresse Cheese and Shinglish cheese were distributed in Southern California, Northern California, Washington State, Minnesota, Nevada, Oklahoma, Texas, Tennessee,Arizona and Michigan to Mediterranean specialty markets.

Both cheeses Cedar brand Shinglish firm unripened cheese, delivered before November 13, 2011 UPC: 78546 10000 and Cedar brand Tresse firm unripened cheese, delivered before November 13, 2011 UPC 78546 01000 were manufactured and recalled by Fromagerie Marie Kade, in Quebec Canada.  Both cheeses are vacuum packed and bear the picture of a green cedar tree, pictured at http://www.fromageriemariekade.com/Produits.htm .

Kradjian has recently been notified by our supplier that the above lot number of this product has the potential to be contaminated with Listeria monocytogenes.

Consumers who have purchased Cedar brand Shingilish or Tresse cheese are urged to return it to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-866 825 2633 9AM to 5PM SPT Monday through Friday, except for holidays.

 

FEMININE HYGIENE

USA Far Ocean Group Inc. (U.S.A. Far Ocean), is voluntarily recalling the Company's two products sold as cosmetic under the names Vagifresh Ball  and Vagifresh Gel. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid). Vagifresh Ball and Vagifresh Gel products are applied by inserting deeply into the vagina for a prolonged period of time. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Vagifresh Gel sample found the product contains benzocaine, the active ingredient for many anesthetic drug products. In addition, FDA analysis of Vagifresh Ball sample found the product contains bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, Leuconostoc spp.

The effect of the absorption of the amount of Benzocaine contained in Vagifresh Gel is unknown, but there is the possibility of an adverse reaction or unknown drug-drug interaction. The effect of the bacterial contamination in VagiFresh Ball is unknown and difficult to assess.  No illnesses have been reported to the Company to date in connection with these products.  The FDA has also determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  Following products are involved in this voluntary recall:

Product

Package Size

UPC Codes

Vagifresh Ball

3 tablets individual pack/packed with Female One

689076499156

Vagifresh Gel

2 fl.oz. tube individual pack/Packed with Female One

689076499057

All lots of the listed products are affected by this recall.

These products were sold via herbal stores, beauty shops, drug stores, internet and mail order. U.S.A. Far Ocean is taking necessary steps to contact wholesalers, retailers and customers for the return of these products. Consumers in possession of these products should stop using it immediately and contact their physician if they experienced any problem that may be related to using any of these products.
Consumers in possession of products should also return any unused products to their immediate supplier for a direct refund. Customers with questions can call USA Far Ocean Group, Inc. at 626-560-2435 Monday through Sunday between 9 a.m. and 5 p.m. (PST) for further instructions or information with respect to the return and refund process.

U.S.A. Far Ocean is committed to providing our customers with high quality, pure and safe products. We are investigating the root cause in the manufacturing processes that has lead to this voluntary recall. We are taking every measure to ensure the quality and purity of any product made by our manufacturers so that this will never happen again in the future. We are extremely sorry and hope that you will not lose faith in our brand.

Any adverse reactions or quality problems experienced with the use of any of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/MedWatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.

Fax: 1-800-FDA-0178