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Posts tagged ‘Recall’

13
Jan

Apple Cider Recall – Pepin Heights Orchards (Jan. 2012)

Pepin Heights Orchards Issues Cider Advisory

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.



8
Nov

Rice – A – Roni Recall – Rice Pilaf Flavor

Rice-A-Roni Issues Voluntary
Recall on a Small Quantity of Specific Family Size Rice-A-Roni Rice
Pilaf Flavor Product Due to Undeclared Milk Allergen

FOR IMMEDIATE RELEASE
– November 4, 2011 – Rice-A-Roni has initiated a voluntary recall on a
small quantity of specific family-size boxes of Rice-A-Roni Rice Pilaf
flavor due to an undeclared milk allergen.  This product was originally
distributed to stores located in California and Arizona. People who
are allergic to milk run the risk of a serious or life-threatening
allergic reaction if they consume this product.

The affected
product is limited to 10.8 ounce family-size boxes of Rice-A-Roni Rice
Pilaf flavor with the UPC Bar Code ending in 43004 and Best
Before Date of JUL 30 12 B stamped on the bottom of the box. Consumers
with a milk allergy who have this product in their possession should
return it to the retailer where it was purchased for a full refund.

No other Rice-A-Roni or Pasta Roni products are affected. People who do not have milk allergies can eat this product without concern.

Rice-A-Roni
is in the process of recovering the product involved and is in contact
with the Food and Drug Administration (FDA) to ensure the continued
safety of those consumers who may be impacted by this issue.
The recall was initiated after it was discovered that the product may have had cross contact with products that contain milk.

Consumers with questions may contact us by calling the toll-free hotline at 800-421-2444 or visit ricearoni.com.

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22
Oct

Fiber One Bars Recall Due to Label Errors

General Mills Issues Voluntary Class One Recall of One Day’s Production of
Chocolate Flavor Fiber One 90-Calorie Chewy Bars


FOR IMMEDIATE RELEASE – October 20, 2011 – General Mills is voluntarily recalling a single day’s production of Chocolate flavor Fiber One 90-Calorie Chewy Bars because of a labeling issue.  Product produced on this date may have been packaged incorrectly, and may contain sensitive ingredients not listed on the box’s ingredient label, including the potential allergen peanuts.

A production error resulted in a limited number of properly labeled, individually wrapped Chocolate Peanut Butter flavor Fiber One 90-Calorie Chewy Bar packages being inserted into 5-count boxes labeled as Chocolate Flavor Fiber One 90-Calorie Chewy Bars.

There have been no reports of allergic reactions or illnesses associated with this product, however, the possibility of an unlabeled allergen makes this a Class One recall.

This voluntary recall includes only 5-count boxes of Chocolate Flavor Fiber One 90-Calorie Chewy Bars with the following “Better if Used By” date printed on the top of the box:

19MAY2012BV

Individually labeled foil packages of Chocolate Peanut Butter flavor Fiber One 90-Calorie Chewy Bars are visibly different from the Chocolate flavor Fiber One 90-Calorie Chewy Bars product depicted on the incorrect box.  Rather than containing Chocolate flavor Fiber One 90-Calorie Chewy Bars, the box could contain Chocolate Peanut Butter flavor Fiber One 90-Calorie Chewy Bars.

Consumers allergic to peanuts, or who are unsure of whether they are allergic to peanuts, should not consume Fiber One 90-Calorie products from 5-count boxes bearing the Better if Used By date 19MAY2012BV on the top of the box, and should contact General Mills for replacement or a full refund.

No other varieties or production dates of Fiber One products are affected by this recall.
Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-231-0308.
Photo: Product Labels



14
Oct

Contact Lenses Recall – Avaira™ Toric Lenses – Oct 2011

CooperVision Continues the Voluntary Recall of Avaira™ Toric Contact Lenses

FOR IMMEDIATE RELEASE – October 13, 2011 – In full cooperation with the United States Food and Drug Administration, CooperVision, Inc. is continuing to work with the FDA, distributors, customers, eye care practitioners and lens wearers to complete the worldwide recall initiated on August 19, 2011 on certain lots of Avaira™ Toric contact lenses.

“Our first priority is always the health and safety of all CooperVision lens wearers and as such we responded quickly to complaints from our customers by initiating a voluntary recall” said Christine Moench, vice president, Global Regulatory Affairs and Quality Assurance. “We want to ensure that all consumers are aware of this action and know where to go for more information.”

If you wear Avaira Toric contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately.  Contact your eye care practitioner for advice.
If you wear Avaira Toric contact lenses and are not experiencing symptoms, CooperVision recommends that you:

  • Go to the CooperVision recall web page at www.coopervision.com/recall, and enter the lot number of your package to determine whether your lenses have been recalled.
  • Alternatively, you may contact us on our toll-free consumer hotline (1-855-526-6737)
  • If your lenses have been recalled, immediately remove your existing lenses, discontinue lens wear; and return your lenses to your eye care practitioner or point of purchase. 

The recall was initiated because of the unintended presence of a residue on certain lots of Avaira Toric lenses, which may cause hazy vision, discomfort, or eye injuries requiring medical treatment. Not everyone experiences the same symptoms. Since the initiation of the recall, the company has received some additional complaints of severe eye pain. Avaira Toric contact lens wearers that experience any symptoms should stop wearing the lenses immediately and speak with their eye care practitioner.

We have ongoing relationships with practitioners to continue to identify all the affected lots in the market. To date, the recall has impacted approximately 600,000 Avaira Toric contact lenses in the U.S. 

As part of the recall, CooperVision notified its customers and requested eye care practitioners contact their patients regarding this recall. Because CooperVision lenses are sold through distributors and eye care practitioners, communication efforts have been focused through these channels in order to most effectively reach lens wearers. Within the first two weeks of the initiation of the recall on August 19, 2011, CooperVision completed the following actions:

  • Sent worldwide recall notifications to more than 9,000 Avaira Toric CooperVision customers.
  • Contacted more than 7,000 U.S. eye care practitioners who have received or sampled Avaira Toric contact lenses.
  • Issued a press release via GlobeNewswire from CooperVision’s parent, The Cooper Companies, regarding the voluntary recall of limited lots of CooperVision Avaira Toric lenses.
  • Included information on the CooperVision website for lens wearers to easily and quickly check if their lenses are impacted (www.coopervision.com/recall), established a toll-free consumer hotline (1-855-526-6737), and included an informational notice on www.coopervision.com.
  • Instructed authorized distributors to send back all Avaira Toric products – not just specific lot numbers – so that CooperVision could ensure that affected lenses were removed.
  • Provided retailers and distributors access to patient communications materials – including post cards and e-mail messages – to send to Avaira Toric lens wearers impacted by the recall.
  • Worked with eye care practitioners to specifically remove affected lots of Avaira Toric products, by providing them with more than 3,500 customized reports detailing affected lots specific to their location.
  • Deployed customer care resources to answer questions from patients, and a specialized team of customer care representatives were made available to contact patients on behalf of eye care practitioners.

The efficient and effective implementation of this recall remains a priority for CooperVision.

About CooperVision
CooperVision, a unit of The Cooper Companies, Inc. (NYSE: COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges; such as astigmatism, presbyopia and ocular dryness; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, thereby creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

Contact lenses are medical devices and can only be prescribed and dispensed by a licensed eye care professional.

###

Photo: Product Labels
Recalled Product Photos Are Also Available on FDA’s Flickr Photostream.



11
Aug

Strawberry Recall August 2011

Fresh Strawberries From Washington County Farm Implicated In E. coli O157 Outbreak In NW Oregon

Oregon Public Health officials have identified fresh strawberries from a Newberg farm as the source of a cluster of Escherichia coli O157:H7 infections that sickened at least 10 people last month, including one person who died.

The strawberries were produced last month by Jaquith Strawberry Farm located at 23135 SW Jaquith Road in Newberg. Jaquith finished its strawberry season in late July, and its strawberries are no longer on the market. Jaquith sold its strawberries to buyers who then resold them at roadside stands and farmer’s markets.
Health officials are urging consumers who may have purchased strawberries grown on this farm to throw them out. Strawberries that have been frozen or made into uncooked jam are of particular concern. Cooking kills E. coli O157:H7 bacteria.

“If you have any strawberries from this producer—frozen, in uncooked jam, or any uncooked form—throw them out,” says Paul Cieslak, M.D., from Oregon Public Health Division. He says people who have eaten the strawberries, but remain well need take no action. The incubation period for E. coli O157:H7 is typically two to seven days.

None of the following have been implicated in this outbreak:

  • Berries other than strawberries.
  • Strawberries sold since Aug. 1.
  • Strawberries sold south of Benton County or east of Multnomah County.
  • Strawberries sold in supermarkets.
  • Strawberries picked at Jaquith Strawberry Farm’s U-pick field.

Ten people have confirmed E. coli O157:H7 infection caused by a single strain. They include residents of Washington, Clatsop, and Multnomah Counties. Six other people in northwest Oregon also have recently developed E. coli O157:H7 infection and appear to be part of this outbreak.

Of the confirmed cases, four have been hospitalized, and one elderly woman in Washington County died from kidney failure associated with E. coli O157:H7 infection. There were twelve females and four males among the cases, and their ages ranged from 4 to 85. They fell ill between July 10 and July 29.

Cieslak, manager of the Oregon Public Health’s communicable disease section, said his team has been working with county public health officials and the Oregon Department of Agriculture on tracking the infection cases. When a potential outbreak is investigated, public health officials ask those who’ve been sickened, family members and health care providers a slate of questions to find common exposures and “trace back” to the source.

“If someone gets sick, we ask questions about everything from what they’ve eaten, to whether they’ve been to common gatherings, to whether they’ve been swimming in a particular place, and then out of this we try to find commonalities,” he said. “The commonality among these cases has been strawberries at roadside stands and farmer’s markets supplied by this one farm last month.”

E. coli is a common inhabitant of the gastrointestinal tract and is usually harmless. But E. coli O157:H7 is a strain of the bacterium carried by some animals, that can contaminate food and water, and that produces toxins that can cause mild to severe intestinal illness, including severe cramps and diarrhea that is often bloody. Some patients develop complications that require hospitalization. About 5 percent of infected persons, especially young children and the elderly, suffer serious and potentially fatal kidney damage.
Antibiotics are not recommended for treatment of E. coli O157:H7 infection, and they may actually make kidney failure more likely. People infected with E. coli O157 should rest and drink plenty of fluids to reduce fatigue and dehydration.

Public health officials emphasize that fruits and vegetables are still important to a healthy diet; at least five servings per day are recommended. However, people need to take the following precautions with any uncooked produce:

  1. Wash fruits and vegetables thoroughly before eating them.
  2. Keep fruits and vegetables and other raw food separated from cooked food
  3. Wash your hands thoroughly with soap after handling raw foods, as well as before eating, after using the toilet, and after changing diapers.



10
Mar

Peppermint and Herbal Tea Blend Recall – Salmonella Risk, March 2011

REMEDYTEAS Voluntarily Recalls Peppermint Organic Herbal Tea And Organic Herbal Tea Blend Because Of Possible Health Risk

Contact:
Remedy Teas
206 323 4832
info@remedyteas.com
 

FOR IMMEDIATE RELEASE – March 8, 2011 – RemedyTeas announced a voluntary recall of 20 lbs of Peppermint Organic Herbal Tea produced by Aromatics Inc., Basin City, WA, because it has the potential to be contaminated with Salmonella. Salmonella is an organism which 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 on Salmonella, please visit the Centers for Disease Control and Prevention’s Web site at http://www.cdc.gov1 or call 800-CDC-INFO (800-232-4636).

The recall was as the result of a batch sample testing program by the vendor after it received a notification of possible contamination which revealed that the finished products contained the bacteria. The vendor has ceased the production and distribution of the product as the FDA and the vendor continue their investigation as to the origin of the contamination. RemedyTeas has not caused the contamination of Salmonella and RemedyTeas has ceased distribution of products affected by the vendor’s recall.

The #137 Peppermint Organic Herbal Tea or #120 Tranquility Herbal Tea were distributed in the RemedyTeas retail store and through mail and internet orders. #137 Peppermint Organic Herbal Tea or #120 Tranquility Herbal Tea is sold measured to customers orders in retail stores and sold in 2 oz pre-packaged pouches by mail order or internet. There are no lot/batch identifying markings on the store or ecommerce packaging. Retail stock of #137 Peppermint Organic Herbal Tea was sold between January 18, 2011 and March 4, 2011. Retail stock of #120 Tranquility Herbal Tea was sold between February 22, 2011 and March 4, 2011. Any purchases not within those dates are not affected by this recall.

While no illness related to this voluntary recall has been reported to date, any potential health risk is significantly reduced when following the printed brewing instructions on the package or available online, i.e. using 205 F water temperature.

Consumers who have purchased #137 Peppermint Organic Herbal Tea or #120 Tranquility Herbal Tea are urged to return it to the place of purchase for a full refund. Consumers may also contact RemedyTeas Customer Service at 206 323-4832 (M – F from 7.00 A.M. until 11:00 P.M., PST) for instructions on how to return the product.



28
Dec

Whole Foods Market Ginger Bread Recall, Dec. 2010



14
Dec

Rolaids Softchews Recall – December 2010 – Wood and Metal Pieces in Product

McNeil Consumer Healthcare Announces Voluntary Recall Of All Lots Of Rolaids® Extra Strength Softchews, Roldaids® Extra Strength Plus Gas Softchews, And Roldaids® Multi-Symptom Plus Anti-Gas Softchews Sold In The United States

Contact:
McNeil Consumer Healthcare
http://www.rolaids.com9
1-888-222-6036

FOR IMMEDIATE RELEASE – December 9, 2010 – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States. McNeil is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. The company’s investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

While our investigation is ongoing we have suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews and will not restart production until corrective actions have been implemented.

Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com10
or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Product Information: Product NDC numbers can be located on the label of the package above the brand name. Lot Numbers and Expiration Dates can be found on back, side or bottom label of the package. If you cannot find the NDC number, lot number, or expiration date on the label, Click here13 for examples or call the Consumer Care Center at 1-888-222-6036.

CLICK HERE14 TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.

FULL RECALLED PRODUCT LIST:

Product Name Lot Number UPC
ROLAIDS® Extra Strength Softchews, Wild Cherry
ROLAIDS® Extra Strength Softchews, Wild Cherry, 6 count 9015A, 9016A, 9019A, 9140A, 9138A,9210A, 9211A,9315A, 9316A 312547655200
ROLAIDS® Extra Strength Softchews, Wild Cherry, 18 count (3 packs of 6 count) 9075A, 9076A, 9103A, 9098A, 9104A, 9239A, 9240A, 9348A 312547655255
ROLAIDS® Extra Strength Softchews, Wild Cherry, 42 count (7 packs of 6 count) 9065A, 9068A, 9069A, 9131A, 9132A, 9208A, 9209A, 9286A, 9287A 312547655316
ROLAIDS® Extra Strength Softchews, Cherry
ROLAIDS® Extra Strength Softchews, Cherry, 6 count 0109A, 0114A, 0115A, 0134A, 0135A, 0165A, 0238B, 0239A, 0239C, 0262A, 0264A 312547655200
ROLAIDS® Extra Strength Softchews, Cherry, 18 count bag 9349AG2, 9350AG1, 0015AG2, 0015AG3, 0050AG1, 0051AG1, 0053BG2, 0106BG2, 0107AG1, 0108AG1, 0108BG3, 0108CG1, 0129BG1, 0133AG1, 0133AG2, 0165BG2, 0191BG1, 0191CG1, 0191DG1, 0213AG2, 0238AG1, 0238AG2, 0246AG1 300450649188
ROLAIDS® Extra Strength Softchews, Cherry, 36 count bag 9350AG2, 0012AG1, 0013AG1, 0014AG1, 0015AG1, 0015AG4, 0050AG2, 0053AG2, 0053BG1, 0053BG2, 0094AG1, 0106AG1, 0106BG1, 0108AG2, 0108BG2, 0191AG1, 0139BG2, 0165BG1, 0191BG1, 0207AG1, 0207AG2, 0213AG1, 0227AG1, 0246AG2, 0247AG1, 0265AG1, 0266AG1 300450649362
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 6 count 9005A, 9006A 312547065733
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 12 count (2 packs of 6 count) 9022A, 9027A, 9118A, 9119A, 9195A, 9196A 312547065757
ROLAIDS® Extra Strength plus Gas Softchews, Tropical Fruit, 36 count (6 packs of 6 count) 9166A, 9167A 312547065771
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 6 count 0017B, 0095A, 0096B, 0259A, 0260A 300450657060
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 12 count bag 9351BG1, 9352AG1, 0016AG1, 0059AG2, 0059BG1, 0059BG2, 0060AG2, 0167AG2, 0167AG3, 0203AG1, 0204AG1 300450657121
ROLAIDS® Multi-Symptom plus Anti-Gas Softchews, Tropical Fruit, 24 count bag 9352AG2, 9352BG2, 0016AG2, 0017AG1, 0057BG1, 0058AG1, 0059AG1, 0059BG3, 0060AG1, 0129AG1, 0132AG1, 0167AG1, 0167BG1, 0204AG2, 0205AG1, 0230AG1, 0231AG1 300450657244

CLICK HERE15 TO FIND OUT IF YOUR ROLAIDS® SOFTCHEWS PRODUCT IS PART OF THE DECEMBER 9, 2010 RECALL.
CLICK HERE16 FOR A REFUND OF YOUR PRODUCT
CLICK HERE17 TO SEE FREQUENTLY ASKED QUESTIONS
CLICK HERE18 FOR INFORMATION ABOUT RECALLS OF ROLAIDS® AND OTHER PRODUCTS



21
Oct

Cantaloupe Recall in and Around Detroit Michigan – Oct. 2010

Del Monte Fresh Produce N.A., Inc. Announces Limited Voluntary Cantaloupe Recall

FOR IMMEDIATE RELEASE – October 21, 2010 – Del Monte Fresh Produce N.A., Inc (“Del Monte Fresh”) announced today the voluntary recall of certain cantaloupes grown in and shipped from Arizona. The affected product was distributed to limited customers in and around Detroit, Michigan and is being recalled because these cantaloupes have the potential to be contaminated with Salmonella.
Persons infected with Salmonella may experience a variety of symptoms and illnesses. 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 more severe illnesses and potentially can be fatal if untreated.
Approximately eighty one (81) cartons of cantaloupes, each containing fifteen (15) cantaloupes per carton, were distributed to wholesalers in Detroit who in turn sell to other wholesalers and or to retail and foodservice outlets beginning on October 11, 2010. The cantaloupes have a light brown color skin on the exterior; with orange flesh. Each cantaloupe has a Del Monte® sticker with the words “Cantaloupe USA”. The cantaloupes were distributed for sale in bulk in cardboard cartons. 
The recalled cartons of cantaloupes are dark brown cardboard with the “Del Monte” logo in red lettering and “cantaloupes” in yellow lettering on a green background. The cantaloupes have the lot codes W-11-147-43-size 15 or W-11-14-19 size 15.
The cantaloupe recall is being implemented as a result of a random test directed by the USDA and carried out by the Michigan Department of Agriculture. Although no illnesses have been reported, Del Monte Fresh voluntarily decided to recall the potentially affected lot.
Consumers who believe that they are in possession of uneaten cantaloupe affected by this recall may contact Del Monte Fresh at any time by calling 1-800-659-6500 or email Del Monte Fresh at Contact-US-Executive-Office@freshdelmonte.com.

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20
Oct

Tylenol Recall – Oct 18, 2010

McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of TYLENOL® 8 Hour Caplets 50 Count Sold in The United States and Puerto Rico

Comsumer Contact:
1-888-222-6036
Media Contact:
Marc Boston,
215-273-7649 (office)
215-429-7034 (mobile)
FOR IMMEDIATE RELEASE – October 18, 2010- Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL® 8 Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil for this lot were temporary and non-serious.
The product lot number for the recalled product can be found on the side of the bottle label.  
FULL RECALLED PRODUCT LIST: 
Product Name
Lot Number
UPC Code
Tylenol® 8 Hour Caplet 50 count
BCM155
3 0045-0297-51 8

Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com9 or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).  
###

Photos: Product Labels

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