Thread: Fda recalls - 2012

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Alpine Slicing and Cheese Conversion Company Issues Voluntary Recall of
“Edelweiss Creamery Premium Fondue Blend” Because of Possible Health Risk

Contact:
Consumer:
Vicki Bergendal
608-934-5707
ascserv@gmail.com

FOR IMMEDIATE RELEASE - December 31, 2011 – Alpine Slicing and Cheese Conversion Company is voluntarily recalling “Edelweiss Creamery Premium Fondue Blend” because it has 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.

No illnesses have been reported.

Approximately 492 lbs of the recalled Edelweiss Creamery Premium Fondue Blend was distributed to:

Horrock’s in Lansing, MI (7420 W. Saginaw Hwy, Lansing, MI 48917)
Metcalfe’s Markets in Wisconsin
Maple Leaf Cheese Outlet in Juda, Wisconsin
Gempeler’s Supermarket in Monticello, Wisconsin
Sprouts Farmers Market in Chula Vista, California (Only the location at 690 3rd Ave, Chula Vista, CA, 91910)
Sunflower Farmers Markets in Texas, Oklahoma, Arizona, Colorado, New Mexico, Utah, Nevada, and California
between November 1, 2011 and December 30, 2011. The Fondue Blend packages were packed in 16oz packages with the red and blue label “Edelweiss Creamery Premium Fondue Blend”. The packaging lists the UPC code 758590116914 and the identifier code 290A11, both of which are located on the back of the package.

Alpine Slicing & Cheese Conversion Company discovered the issue during testing of its products by an independent laboratory. Laboratory testing has confirmed that certain products processed on the shred line contained Listeria monocytogenes. Therefore, other products produced on the same line, even if they have been tested and found to be negative, have the potential to be contaminated.

Alpine Slicing and Cheese Conversion Company has contacted the FDA and issued the recall to retail grocery stores and distributors in all of the affected states. The company has ceased the production and distribution of the product as FDA and the company continue their investigation into matter. All remaining inventory has been quarantined.

Consumers are urged to stop consuming the recalled product and return all recalled products to the store of purchase. Consumers with questions may contact Alpine Slicing and Cheese Conversion Company at 608-934-5707, from 9:00 AM – 5:00 PM CST, Monday through Friday, or by email at ascserv@gmail.com.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

Thanks for the information John Doe.

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Rich Products Corporation announces nationwide voluntary recall of 1/4 (Quarter) Sheet Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored

Contact:
Consumer:
Rich’s Product Helpline
1-800-356-7094 (United States)
1-800-263-8174 (Canada)

Media:
Dwight Gram
716-878-8749

FOR IMMEDIATE RELEASE - January 5, 2012 -Rich Products Corporation recalled its 1/4 (quarter) Sheet Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored (Product Code: 00405) on January 5, 2012, because small plastic fragments from the packaging were found on top of the product. The size of the fragments range from 1/4 (one fourth) to 3/4 (three fourths) inches.

Rich Products Corporation has not received any reports of injuries connected with 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: 00049800004054. Product produced after July 10, 2011 is affected.

The 1/4 (Quarter) Sheet 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. There also have been some sales to foodservice customers. Rich’s has already notified all of its distributors and customers who have received the product in question, and has 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) or 1-800-263-8174 (Canada) between the hours of 8:30 a.m. and 5:00 p.m. EST. Voice mail is available after hours.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

Originally Posted by kathyet

Thanks for the information John Doe.

Your welcome. It's all part of the service.
I search government sites looking for info that they make available but that the media doesn't pass on to everyone.

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Bloch’s Best Inc Issues Allergy Alert on Undeclared Eggs in Laromme Brand Vanilla Rugelach in 14 oz. Round Containers

Contact:
Consumer:
(845) 352-8811

Media:
Sam Bloch
(845) 352-8811


FOR IMMEDIATE RELEASE - January 6 , 2011 - Bloch’s Best Inc doing business as Laromme of Monsey, NY is recalling Laromme brand Vanilla Rugelach in 14 oz. round containers because it may contain undeclared eggs. People who have an allergy or severe sensitivity eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Laromme brand Vanilla Rugelach was distributed in retail stores throughout Massachusetts, Maryland, and New Jersey.

The product comes in a 14 oz. round clear plastic container with UPC 87062500954-8. A total of 10 cases, with 18 containers each, were distributed between November 2, 2011 and December 22, 2011.

To date, one report of illness has been reported.

The recall was initiated after it was discovered that product containing egg was distributed in packaging that did not reveal the presence of egg. Subsequent investigation indicates the problem was caused by a change in the label design used by our supplier.

The product label has been corrected to properly identify all ingredients, including any allergens, for future production of this product. Stores which received the product have been instructed to remove it from their shelves.

Consumers who purchased 14 oz. Laromme Vanilla Rugelach are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 845-352-8811 between 11:00am and 5pm, Monday to Friday.

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Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

January 8, 2012 5:13 PM

Recall of Excedrin, NoDoz, Bufferin

(AP) BASEL, Switzerland — Novartis is recalling some bottles of Excedrin, NoDoz, Bufferin and Gas-X Sunday over concerns that the bottles could contain stray pills from other medicines, or chipped or broken tablets.


The news follows Novartis' recent decision to temporarily suspend production at its Lincoln, Neb., plant for "maintenance and other improvement activities."


The Swiss drug maker said it implemented the recall, which affects U.S. retailers, voluntarily and is working with the Food and Drug Administration during the process.


It became aware of the potential problem during an internal review that identified broken and chipped pills, and inconsistent bottle packaging that could cause pills to be mixed up. The company said it wanted to make sure that customers didn't take any pills that they might be allergic to or that might become dangerous when mixed with their other medications, though it also said that there have been no such reports from consumers.


Novartis said that some of the bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014, or earlier will be subject to the recall.


Some of the packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013, or earlier will also be affected.


The company said it will post more information Monday at www.novartisOTC.com. Customers can also call the company at 1-888-477-2403 Monday to Friday, 9 a.m. to 8 p.m. EST.

http://www.cbsnews.com/8301-204_162-...odoz-bufferin/

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall Of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

Contact:
Consumer:
1-888-477-2403 Monday-Friday 9 a.m. to 8 p.m. Eastern Time

Media:
Julie Masow
Novartis Corporation
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com

List of products affected in this recall (PDF 206 kb)

FOR IMMEDIATE RELEASE - Parsippany, January 8, 2012 – Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.

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

Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. NCH is not aware of adverse events reported with the issues leading to the recall.

These over-the-counter products were distributed nationwide to wholesalers and retailers.

Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.

Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers should visit our website at www.novartisOTC.com1 as of January 9, 2012. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm2
Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm3.
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178
These actions announced today, highlight the strong Novartis commitment to a single quality standard for the Novartis Group. The Novartis Group is making the necessary investments and committing the right resources to ensure these are implemented across the entire Novartis Group network. The high quality of Novartis products and operations has been critical to building the Novartis Group reputation over the past 15 years. Novartis Group is committed to ensuring the highest standard for patients who rely on our products and medicines.

Novartis Consumer Health Inc. plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The Novartis Consumer Health Inc. Lincoln, NE facility produces a variety of products mainly for the US market with annual sales value of less than 2% of Novartis Group sales. At this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility.

Novartis commitment to quality
The Novartis Group is fully committed to ensuring the quality, safety and integrity of its products. All Novartis Group companies have a clear commitment to patients and Health Authorities to ensure high quality standards for all our products and services. Novartis Group companies stand behind the safety and efficacy of their products, and are fully committed to maintaining high quality standards at all production sites in the US and around the world. All Novartis Group products are subjected to strict manufacturing, testing and monitoring standards. Where they fall outside the standards, Novartis Group companies take actions to correct the issue and may recall products as a precaution.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” “will,” “committed,” “commitment,” “plans,” or similar expressions, or by express or implied discussions regarding the potential length of the shutdown of our Lincoln, NE production facility, regarding the potential for any further regulatory actions at the Lincoln, NE production facility, regarding the potential for any further quality issues arising at any additional Novartis manufacturing facilities, or regarding the potential financial impact of the Lincoln, NE facility shutdown. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that our Lincoln, NE production facility will reopen at any particular time. Nor can there be any guarantee that actions described in this release will be the only regulatory actions required at the Lincoln, NE facility. Neither can there be any guarantee that further quality issues will not arise at any additional Novartis Group manufacturing facilities. Nor can there be any guarantee as to the potential financial impact on Novartis resulting from the shutdown of the Lincoln, NE production facility. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing issues, including unexpected inabilities to satisfy regulators’ requirements for the reopening of the Lincoln, NE production facility; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis Group provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2010, the Group’s continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com4.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis5.

# # #

Novartis Media Relations

Julie Masow
Novartis Corporation
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
julie.masow@novartis.com

Pamela McKinlay
Novartis Consumer Health, Inc.
+1 973 503 7337(direct)
+1 862 221 0151(mobile)
pamela.mckinlay@novartis.com

e-mail: us.mediarelations@novartis.com

Milicent Brooks
Novartis Consumer Health, Inc.
+1 973 503 7483(direct)
+1 973 479 2078 (mobile)
milicent.brooks@novartis.com

CONTINUE BELOW.

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis6
For questions about the site or required registration, please contact: journalisthelp@thenewsmarket.com.
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Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

FDA steps up testing for fungicide in orange juice

WASHINGTON – The Food and Drug Administration says it will step up testing for a fungicide that has been found in low levels in orange juice.

FDA officials said they aren't concerned about the safety of the juice but will increase testing to make sure the contamination isn't a problem. In a letter to the juice industry Monday, the agency said that an unnamed juice company contacted FDA in late December and said it had detected low levels of the fungicide carbendazim in the company's own orange juice and also in its competitors' juice. Fungicides are used to control fungi or fungal spores in agriculture.

Carbendazim is not currently approved for use on citrus in the United States, but is used in Brazil, which exports orange juice to the United States. An FDA spokeswoman said the company's testing found levels up to 35 parts per billion of the fungicide, far below the European Union's maximum residue level of 200 parts per billion. The United States has not established a maximum residue level for carbendazim in oranges.

MORE: FDA examines level of arsenic in apple juice
In the letter to the Juice Products Association, FDA official Nega Beru said the agency will begin testing shipments of orange juice at the border and will detain any that contain traces of the chemical. Because it is not approved for use in the United States, any amount found in food is illegal.

Beru said that because the FDA doesn't believe the levels of residue are harmful, the agency won't remove any juice currently on store shelves. But he asked the industry to ensure that suppliers in Brazil and elsewhere stop using the fungicide.

"If the agency identifies orange juice with carbendazim at levels that present a public health risk, it will alert the public and take the necessary action to ensure that the product is removed from the market," he said.

The discovery comes after the agency said it would also step up testing for arsenic in apple juice. FDA officials said last year that the agency is considering tightening restrictions for the levels of arsenic allowed in the juice after consumer groups pushed the agency to crack down on the contaminant.

Studies show that apple juice has generally low levels of arsenic, and the government says it is safe to drink. But consumer advocates say the FDA is allowing too much of the chemical — which is sometimes natural, sometimes man made — into apple juices favored by thirsty kids.

Patty Lovera of the consumer group Food and Water Watch said the federal government needs to rely on its own testing, not that of the companies.

"The federal government needs to set consistent, meaningful, enforceable standards for all toxins," she said.

FDA testing for fungicide in orange juice - USATODAY.com

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Pepin Heights Orchards Issues Cider Advisory

Contact:
Media:
Chris Sandwick
612-414-5435

Consumers:
Pepin Heights
800-652-3779

FOR IMMEDIATE RELEASE - January 6, 2012 -Pepin Heights Orchards is advising consumers to discard Pepin Heights brand Honeycrisp Apple Cider with a “Use By” date on the label of Feb 09 2012. The product was packaged in half-gallon plastic jugs and sold and distributed in Minnesota, Iowa and Wisconsin.

This advisory is precautionary. No illnesses have been reported.

The advisory applies only to Honeycrisp cider with the “Use By” date of Feb 09 2012. No other batch of Honeycrisp cider or any other Pepin Heights Orchards products are included in the advisory.

Retailers and consumers with questions may call Pepin Heights at (800) 652-3779, Monday-Friday, 8 a.m.-5 p.m. Central Time. Consumers seeking a refund should mail the label from the front of the affected cider to: Pepin Heights Orchards, Attn: Cider Refund, 1753 South Hwy 61, Lake City, MN 55041.

The company issued the advisory in cooperation with the Minnesota Department of Agriculture. Routine state tests indicated that samples of Pepin Heights Brand Honeycrisp Apple Cider with a “Use By” date of Feb 09 2012 may contain slightly elevated levels of patulin, which is a natural byproduct of several species of mold.

“We are issuing this advisory out of an abundance of caution,” said Chris Sandwick, Director of Sales and Marketing at Pepin Heights Orchards. “We take the safety of our consumers very seriously.”

While the short-term health effects of patulin have not been clearly established, and no illnesses have been attributed to patulin, the U.S. Food and Drug Administration has identified long-term exposure as a potential concern.

Pepin Heights Orchards has invested heavily in state-of-the-art cider processing facilities. It also reviews and updates its safety processes annually and carefully follows its food safety plan, which is reviewed by the Minnesota Department of Agriculture and includes regular onsite inspections of Pepin Heights facilities and practices.

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U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)

Pepin Heights Orchards Issues Cider Advisory