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.
Nestlé USA Announces Voluntary Recall of NESQUIK® Chocolate Powder
FOR IMMEDIATE RELEASE - November 8, 2012 - Nestlé USA announced the voluntary recall of limited quantities of Nestlé NESQUIK® Chocolate Powder in the 10.9, 21.8 and 40.7 ounce canisters. The voluntary recall is limited to only NESQUIK Chocolate Powder, which was distributed nationally. No other varieties of NESQUIK powder or any sizes or flavors of NESQUIK ready-to-drink are affected by this recall.
Nestlé is removing the canisters from distribution because the company was notified by an ingredient supplier, Omya Inc. that it has issued a recall of certain lots of its ingredient, calcium carbonate due to possible presence of Salmonella. Calcium carbonate is used in NESQUIK as an ingredient. There have been no reports of any illnesses or adverse health effects associated with the affected product.
To ensure the safety of consumers, Nestlé is recalling selected NESQUIK Chocolate Powder. The recall is limited to the following sizes, UPC and production codes of NESQUIK Chocolate Powder:
|Size||UPC Code||Production Codes|
|40.7 oz. Chocolate (72 servings)||0 28000 68230 9||2282574810
|21.8 oz. Chocolate (38 servings)||0 28000 68090 9||2278574810
|10.9 oz. Chocolate (19 servings)||0 28000 67990 3||2278574810|
The affected NESQUIK Chocolate Powder was produced during early October, 2012. To locate the production code, consumers should look on the bottom of the canister, adjacent to the consumer expiration date. All affected products have an expiration date of BEST BEFORE Oct 2014.
Consumers who may have purchased the affected NESQUIK Chocolate Powder should not consume it, but instead should return it to the place of purchase for a full refund or contact Nestlé Consumer Services at (800) 628-7679.
The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating or drinking contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.
Nestlé is dedicated to the health and safety of its consumers. For these reasons, the company initiated this voluntary recall. We apologize to our consumers and sincerely regret any inconvenience created by this incident.
Kraft Foods Voluntarily Recalls Jalapeno Variety of Kraft String Cheese With Code Date of 23 Nov 2012
FOR IMMEDIATE RELEASE - October 8, 2012 Kraft Foods Group, Inc. is voluntarily recalling the Jalapeno variety of Kraft String Cheese with the Best When Used By date of 23 NOV 2012 as a precaution due to the possibility that a thin layer of plastic film from the package may remain adhered to the product. If the film sticks to the cheese and is not removed, it could potentially cause a choking hazard.
The following single code date of this product is being recalled:
|Name of Product||Size||Best When Used By Date||UPC|
|Kraft String Cheese – Jalapeno Variety||12 oz bag with
1 oz snacks
|23 NOV 2012||2100002977|
Consumers can find the Best When Used By date on the back of the 12 oz package in the lower-right corner.
No other code dates of Kraft Jalapeno String Cheese and no other varieties of Kraft String Cheese or any other Kraft Foods products are being recalled.
There has been one consumer complaint. Approximately 2,700 cases of the affected product were shipped to customers across the United States. The affected product was not distributed in Canada.
Consumers who purchased the product with the Best When Used By date of 23 NOV 2012 should not eat it. They should return it to the store of purchase for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations Monday through Friday at 1-800-396-2133.
The affected product was produced in Campbell, NY.
ABOUT KRAFT FOODS GROUP
Kraft Foods Group, Inc. (NASDAQ: KRFT) is a new company that has been around 109 years. North America’s fourth largest consumer packaged food and beverage company, Kraft had revenues of approximately $19 billion in 2011. The company has an unrivaled portfolio of products in the beverages, cheese, convenient meals and grocery categories. Its iconic brands include Kraft, Maxwell House, Oscar Mayer, Planters and JELL-O. Kraft’s 25,000 employees in the U.S. and Canada have a passion for making the foods and beverages people love. Kraft Foods Group became an independent company on Oct. 1, 2012 and will be a member of the Standard & Poor’s 500 index. For more information, visit www.kraft.com.
General Mills Issues Voluntary Class One Recall of One Day's Production of Almond Nature Valley Sweet & Salty Nut Granola Bars Contact: Consumer: 1-800-231-0308 Media: Kirstie Foster 763-764-6364 FOR IMMEDIATE RELEASE - September 26, 2012 - General Mills is voluntarily recalling a single day's production of Almond Nature Valley Sweet & Salty Nut Granola Bars because of a labeling issue. Product produced on this date may have been packaged incorrectly, and may contain allergens not listed on the box's ingredient label, specifically peanuts. A production error resulted in a limited number of properly labeled, individually wrapped Peanut Nature Valley Sweet & Salty Nut Granola Bar packages being inserted into 6-count boxes labeled as Almond Nature Valley Sweet & Salty Nut Granola Bars. The Almond Nature Valley Sweet & Salty Nut Granola Bars carton does contain an allergen statement indicating the product "may contain peanuts." There have been no reports of allergic reactions or illnesses associated with this product. This voluntary recall includes only 6-count boxes of Almond Nature Valley Sweet & Salty Nut Granola Bars with one Better if Used By date printed on the top of the box: 26FEB2013 No other varieties or production dates of Nature Valley products are affected by this recall. Consumers allergic to peanuts, or who are unsure of whether they are allergic to peanuts, should not consume Almond Nature Valley Sweet & Salty Nut Granola Bar products from 6-count boxes bearing the Better if Used By date 26FEB2013 on the top of the box, and should contact General Mills for replacement or a full refund. Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-231-0308
Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Salads
FOR IMMEDIATE RELEASE - April 14, 2012 - Dole Fresh Vegetables is voluntarily recalling 756 cases of DOLE® Seven Lettuces salad with Use-by Date of April 11, 2012, UPC code 71430 01057 and Product Codes 0577N089112A and 0577N089112B, due to a possible health risk from Salmonella. Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported in association with the recall.
The Product Code and Use-by Date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in fifteen U.S. states (Alabama, Florida, Illinois, Indiana, Maryland, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin).
No illnesses have been reported in association with the recall. This precautionary recall notification is being issued due to an isolated instance in which a sample of Seven Lettuces salad yielded a positive result for Salmonella in a random sample test collected and conducted by the State of New York.
No other Dole salads are included in the recall. Only the specific Product Codes, UPC codes and April 11, 2012 Use-by-Date of Seven Lettuces salads identified above are included in the recall. Consumers who have any remaining product with these Product Codes should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Food Company Consumer Response Center at (800) 356-3111, which is open 8:00 am to 3:00 pm (PDT) Monday - Friday.
Retailers should check their inventories and store shelves to confirm that none of the product is mistakenly present or available for purchase by consumers or in warehouse inventories. Dole Fresh Vegetables customer service representatives are already contacting retailers and are in the process of confirming that the recalled product is not in the stream of commerce.
Salmonella is an organism that can cause foodborne illness in a person who eats a food item contaminated with it. Symptoms of infection may experience fever and gastrointestinal symptoms such as nausea, diarrhea, vomiting or abdominal pain. The illness primarily impacts young children, frail and elderly people and those with weakened immune systems. Most healthy adults and children rarely become seriously ill.
Kraft Foods Voluntarily Recalls Single Code Date of Planters Cocktail Peanuts
FOR IMMEDIATE RELEASE – April 6, 2012 – Kraft Foods Group, Inc. is voluntarily recalling one code date of Planters Cocktail Peanuts sold in 12 oz canisters (code date 09-Jan-14, UPC 2900007212) because there is a possibility that the product was exposed to water not intended for use in food during the production process.
The following product/code date is being recalled:
|Name of Product||Size||Code Date||UPC|
|Planters Cocktail Peanuts||12 oz canister||09-Jan-14||2900007212|
Consumers can find the code date on the bottom of the canister. No other code dates or any other Planters products are being recalled.
There have been no illnesses reported or complaints related to this product. Kraft Foods is issuing this voluntary recall out of an abundance of caution.
Approximately 3,000 cases of the recalled product were shipped to retail customers across the United States and Puerto Rico. The affected products were not distributed in Canada.
Consumers who purchased the affected code date of this product should not eat them. They should return them to the store of purchase for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-396-2133. Hours of operation are 9 a.m. to 6 p.m. EDT, Monday to Friday.
The affected products were manufactured by Kraft Foods in Suffolk, Va.
- Item : Little Fevers Children’s Fever/Pain Reliever Acetaminophen 160 mg / 5.0 mL Dye Free Cherry 4 oz.
- ITEM UPC: 7-56184-10124-7
- Product Code: 10756184101244A
- The item is on hold until we receive back the response forms.
We are conducting this voluntary recall on the following lots because some of the Acetaminophen may come out of suspension in the product and diminish effectiveness.
7 lots affected that shipped October 2010- March 2012. Any Lots with a 4 digit Lot number, for example #2386, are NOT subject to this recall.
Gerber Voluntarily Withdraws a Specific Batch of Gerber® Good Start® Infant Formula and Offers Replacement Product to Consumers
Contact: Consumer: Gerber Parents Resource Center 1-800-487-7763 Media: David Mortazavi Director of Communications, Gerber Products Company firstname.lastname@example.org
FOR IMMEDIATE RELEASE - March 8, 2012 – Gerber Products Company is proactively retrieving and offering a replacement to consumers who purchased Gerber® Good Start® Gentle powdered infant formula 23.2 ounce plastic package from batch GXP1684 expiration date of March 5, 2013.
The product poses no health or safety risk. However, this product might have an off-odor noticeable to some consumers. In some cases spit-up and other gastrointestinal complaints have been reported.
Consumers who have the product with the batch code and expiration date above should contact the Gerber Parents Resource Center at 1-800-487-7763 for replacement. Additionally, Gerber is working with retailers to retrieve any remaining product from this batch.
Please note, this is limited to only one Gerber® Good Start® Gentle powder manufacturing code, and no other Gerber® or Gerber® Good Start® products are affected or involved.
At Gerber, the safety and quality of our products is our top priority. If parents or caregivers have questions, Gerber is here for them. They can call the Parents Resource Center anytime, day or night, at 1-800-487-7763.
McNeil Consumer Healthcare Announces Voluntary Nationwide Recall of
Infants’ TYLENOL® Oral Suspension, 1 oz. Grape Due to
Dosing System Complaints
Recall Limited to Wholesale and Retail Levels
Fort Washington, PA (February 17, 2012) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (“McNeil”), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants’ TYLENOL® Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). Infants’ TYLENOL® is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
McNeil is initiating this voluntary recall as a precaution after receiving a small number of complaints from consumers who reported difficulty using the Infants’ TYLENOL® SimpleMeasure™ dosing system. SimpleMeasure™ includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. Children’s TYLENOL® products are intended for children two years of age and older and remain available.
No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote. Consumers can continue to use Infants’ TYLENOL® provided the flow restrictor at the top of the bottle remains in place. The company discussed how to use the product’s dosing system in a separate message to consumers also issued today.
If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Consumers can request a refund by visiting www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information.
AVEENO® BABY CALMING COMFORT® LOTION
1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time)
FOR IMMEDIATE RELEASE – January 27, 2012 – Johnson & Johnson Consumer Companies, Inc. is voluntarily recalling from retailers one lot of AVEENO® BABY CALMING COMFORT® LOTION (full product details below) in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall and no action is required by consumers.
This recall is being initiated as a precautionary measure after testing of a product sample by the U.S. Food and Drug Administration (FDA). That test indicated that the lot exceeded the specifications for common bacteria, though extensive testing by an independent laboratory afterward did not show that specifications were exceeded. However, Johnson & Johnson Consumer Companies, Inc. has voluntarily initiated this recall out of an abundance of caution. This action is not being undertaken on the basis of adverse events and the potential for adverse health effects is remote. Other lots of AVEENO® BABY CALMING COMFORT® LOTION are not affected by this recall and remain available.
This recall is being conducted with the knowledge of the FDA.
Consumers who would like a refund or coupon, or who have questions or concerns about the recalled product, should call our Consumer Call Center at 1-877-298-2525 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).
The lot number and UPC code for the recalled product is embossed on the tube.
FULL RECALLED PRODUCT LIST:
|PRODUCT NAME||LOT NUMBER||UPC CODE|
|AVEENO® BABY CALMING COMFORT® LOTION||0161LK||38137-0036456|
Pinnacle Foods Group LLC Issues Allergy Alert On Undeclared Soy Protein In Aunt Jemima Frozen Pancakes
Contact: Consumer: 1-888-299-7646 Media: (973) 541-8620 FOR IMMEDIATE RELEASE - January 27, 2012 - Out of regard and concern for
our consumers, Pinnacle Foods Group LLC is recalling certain Aunt Jemima Frozen Pancakes. The product may contain soy protein, an undeclared allergen. People who have an allergy or severe sensitivity to soy protein may run the risk of an allergic reaction if they consume this product. The voluntary recall was initiated after the Company discovered there may have been a potential cross- contact with product that contained soy protein being produced on the same equipment. There have been no reports of illness as a result of this incident. The Food and Drug Administration has been made aware of this recall. This recall applies only to the following products: “AUNT JEMIMA FROZEN PANCAKES” packaged in cardboard cartons with the UPC codes listed below, which were sold and distributed nationally, with a ‘Recommended Use By Date’ between November 1, 2011 up to and including October 16, 2012. This date can be found in the white box on the end of the carton. Production Code information is as follows:
Retail UPC Code
AUNT JEMIMA PANCAKES BUTTERMILK LOW FAT 12/14.5oz
AUNT JEMIMA OATMEAL PANCAKES 12/14.8oz
AUNT JEMIMA PANCAKES BUTTERMILK 12/14.8oz
AUNT JEMIMA PANCAKES HOMESTYLE 12/14.8oz
AUNT JEMIMA CONFETTI PANCAKES 12/14.8oz
AUNT JEMIMA WHOLE GRAIN PANCAKES 12/14.5oz
If you are allergic to or have a severe sensitivity to soy protein, you should not consume this product. Please return the product to the store where purchased for a full refund. If you are not allergic to soy protein, this product is safe to eat.
This announcement applies only to the AUNT JEMIMA FROZEN PANCAKE products listed above and does not include waffles, French toast, entrees, sandwiches, boxed pancake mixes and syrups. Consumers with questions may contact the Company at 1- 888-299-7646 daily between 9 a.m. and 8 p.m. Eastern Time.
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
1-888-477-2403 Monday-Friday 9 a.m. to 8 p.m. Eastern Time
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
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:
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.
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.
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.