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

Contact:
Consumer
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:

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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

Description

19600- 05100

AUNT JEMIMA PANCAKES BUTTERMILK LOW FAT 12/14.5oz

19600- 05490

AUNT JEMIMA OATMEAL PANCAKES 12/14.8oz

19600- 05820

AUNT JEMIMA PANCAKES BUTTERMILK 12/14.8oz

19600- 05910

AUNT JEMIMA PANCAKES HOMESTYLE 12/14.8oz

19600- 05955

AUNT JEMIMA CONFETTI PANCAKES 12/14.8oz

19600- 06040

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

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.

McNeil Recall of Motrin® IB Tablets and Caplets

Contact:
Consumer:
888-222-6036

December 21, 2011 - McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil) is voluntarily recalling certain lots of MOTRIN® IB 24 count COATED CAPLETS, MOTRIN® IB 24 count COATED TABLETS and MOTRIN® IB 24+6 count COATED CAPLETS from retailers. The products were distributed in the United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica. This is not a consumer level recall, which means that consumers do not need to dispose of or return the product. There is no safety concern if consumers continue taking the product in accordance with its label; however, it is possible there may be a delay in experiencing relief. This action is not being undertaken on the basis of adverse events.

McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. Out of an abundance of caution, we are recalling all the listed products since there is a chance they could experience a similar problem as they approach expiration. If you have any questions or concerns, please call our Consumer Call Center at 1-888-222-6036 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time).

The lot numbers (a full list is attached below) for the recalled product can be found on the side of the carton label.

FULL RECALLED PRODUCT LIST:

P&G Voluntarily Recalls One Production Lot of Dry Dog Food

Contact:
Consumer:
866-908-1569

Media:
Jason Taylor
513-622-3205

FOR IMMEDIATE RELEASE - December 6, 2011 - – The Procter & Gamble Company (P&G) has voluntarily retrieved a single production lot of dry dog food due to aflatoxin levels that were detected above the acceptable limit. This product has already been retrieved from store shelves. No illnesses have been reported in association with this production lot to date, and no other Iams pet food products are involved.

Product affected by this announcement:

The affected product lot was distributed to a limited number of retailers located in the eastern United States (AL, CT, DE, FL, GA, LA, MD, ME, MS, NC, NH, NJ, NY, PA, SC, VA).  These retailers have already removed this product from store shelves.  No other dry dog food, dry cat food, dog or cat canned food, biscuits/treats or supplements are affected by this announcement. 

While no health effects related to this product have been reported, P&G retrieved this product as a precautionary measure.  Consumers who purchased the product listed should stop using the product and discard it and contact Iams at the number below for a replacement voucher.  Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities.  Pets which have consumed this product and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian.         

For further information or a product replacement or refund contact P&G toll-free at 866-908-1569
(Monday – Friday, 9:00 AM to 6:00 PM EST) or www.iams.com¹. 

About Procter & Gamble
Four billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Gain®, Pringles®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Duracell®, Olay®, Head & Shoulders®, Wella®, Gillette®, Braun® and Fusion®. The P&G community includes approximately 135,000 employees working in about 80 countries worldwide. Please visit http://www.pg.com² for the latest news and in-depth information about P&G and its brands.

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RSS Feed for FDA Recalls Information³ [what's this?⁴]

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.

Mars Food US Recalls Two Date Codes of UNCLE BEN’S Whole
Grain White Rice Garden Vegetable Due to Undeclared Milk

Contact:
Consumer:
1-800-548-6253

Media:
Pam Krebs
562-616-7523

FOR IMMEDIATE RELEASE - December 6, 2011 - Mars Food US today issued a voluntary recall of two date codes of UNCLE BEN’s® Whole Grain White Rice Garden Vegetable due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other flavors of UNCLE BEN’s® Whole Grain White Rice or any other UNCLE BEN’s® products are affected.

This product was distributed through retail stores in Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont and Wisconsin.

The recall only affects UNCLE BEN’s® Whole Grain White Rice Garden Vegetable 4.7 oz. (133 g) boxes with the following:

UPC code of 54800 40778
Best before: 08/12
Code dates: 133BA4RP06 and 133BB4RP06

An ingredient supplier improperly included an undeclared milk ingredient in the seasoning mix used for this product. Consumers with milk allergies are advised not to eat the product. All consumers should return the product to the store where it was purchased for a full refund.

Mars Food US has not received any reports of illness or other consumer complaints related to this matter.

Consumers with additional questions should call the UNCLE BEN’S Consumer Care line at: 1-800-548-6253, between the hours of 9:30 a.m. and 5 p.m. (EST) Monday – Friday, or visit www.unclebens.com¹.

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.

Ocean Spray Voluntarily Recalls Limited Quantity of Original Flavor Craisins® Dried Cranberries and Bulk Dried Cranberries Sales

Certain 5-oz, 10-oz, and 48-oz Craisins® Code Dates Affected

Contact:
Consumer:
1-800-662-3263

Media:
Hallie Lewis
617-520-7147
HLewis@webershandwick.com

FOR IMMEDIATE RELEASE - November 25, 2011 -Ocean Spray today announced it has taken the precautionary measure of voluntarily recalling certain production lots of its Original Flavor Craisins® Dried Cranberries product in 5-ounce, 10-ounce and 48-ounce packages as well as bulk sweetened dried cranberries in 10-pound packages due to the possible presence of very small hair-like metal fragments that are unlikely to cause consumer injury.

To date, the company has not received any reports of consumer complaints relating to this recall. No injuries or adverse effects have been reported regarding these products to date. Ocean Spray issued the voluntary recall out of an abundance of caution to ensure the safety of our consumers.

No other Ocean Spray brand products are affected.

The following Ocean Spray Original Flavor Craisins® Dried Cranberries are part of this recall: 

• 5 oz Craisins® UPC: 00293-000
  1. Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED):
     1. Oct 27 2012 M
• 10 oz Craisins® UPC: 29456-000 and 29464-000 
  1. Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED):
     1. Oct 27 2012 M
     2. Oct 28 2012 M
     3. Oct 29 2012 M
• 48 oz Craisins® UPC: 00678-318
  1. Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED):
     1. Oct 27 2012 M
     2. Oct 28 2012 M
     3. Nov 3 2012 M
     4. Nov 4 2012 M
     5. Nov 5 2012 M
     6. Nov 6 2012 M
     7. Nov 7 2012 M
     8. Nov 10 2012 M
     9. Nov 11 2012 M
• 10 lb bulk ingredient & foodservice UPC: 03477-000
  1. Best By Dates (ONLY THESE DATES FOLLOWED BY THE LETTER “M” ARE AFFECTED):
     1. 30 Oct 2013 M
     2. 31 Oct 2013 M
     3. 1 Nov 2013 M
     4. 5 Nov 2013 M

Consumers who have purchased the recalled products are urged to destroy the product, save the UPC label and best by date and contact the Ocean Spray Consumer Hotline at 1-800-662-3263 for a coupon replacement.

The J.M. Smucker Company Announces a Limited Voluntary Recall on Two Specific Best-If-Used-By Dates of 16 oz. Smucker’s® Natural Peanut Butter Chunky Due to Possible Health Risk

Contact:
Consumer
888-550-9555

Maribeth Badertscher
Vice President, Corporate Communications
330-682-3000

FOR IMMEDIATE RELEASE - November 16, 2011 - The J.M. Smucker Company today announced a limited voluntary recall on two specific Best-If-Used-By dates of 16 oz. Smucker’s® Natural Peanut Butter Chunky because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. For more information, please visit the Centers for Disease Control and Prevention’s website at www.cdc.gov¹.

This product was distributed in: Arkansas, Colorado, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and the District of Columbia.

The affected product, which is packaged in 16 oz. jars, is as follows:

• UPC: 5150001701 (located on the side of the jar's label below the bar code)
• Production Codes: 1307004 and 1308004
• Best-If-Used-By dates: August 3, 2012 and August 4, 2012
• Chunky product only (not creamy)
• Impacted product would have been purchased between November 8 - 17, 2011

No other products of The J.M. Smucker Company are affected by this recall.

No illnesses related to this issue have been reported and the product is being recalled out of an abundance of caution for consumer safety.

The recall was initiated as the result of a routine sampling program by the company, which revealed that these finished products may contain the bacteria.

Consumers who have purchased Smucker’s Natural Peanut Butter Chunky with the above Production Code and Best-If-Used-By dates are urged to discard the product immediately and call the company at 1-888-550-9555 for a replacement coupon. The company may require proof of purchase. Consumers with questions can contact the company to speak to a customer service representative at 1-888-550-9555 between Monday through Friday from 9:00 AM - 7:00 PM.

The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

Excedrin Recall