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Current Product Recall Information

Miravalle Foods Inc. Recalls Chile California & Chile Nuevo Mexico Peppers Because of Possible Health Risk
Posted: July 9, 2010

Contact: Carmen Debora /626-279-6337

Miravalle Foods, Inc. S. El Monte, CA is recalling 37,318 lbs. of “Miravalle Chile California & Miravalle Chile Nuevo Mexico” Brand Peppers" distributed between March 15th and May 6th 2010 to some customers in CA, CO, UT, NC, NE, ID, OR and NV because they have the potential to be contaminated with Salmonella, 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.

The recalled Peppers distributed to a small group of customers through direct delivery, distributors and retail stores are in 3oz. (UPC Code: 7 12810-00301 & 7 12810-00304), 6 oz. (UPC Code: 7 12810-60001 & 7 1280-60004), 8oz. (UPC Code: 7 12810-00802 & 7 12810-00803) and 16 oz. (UPC Code: 7 12810-16005 & 7 12810-16007) clear plastic packages under the “Miravalle Chile California & Miravalle Chile Nuevo Mexico” Brand and in bulk 25lb. boxes.

No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after lab analysis of a random sample of the affected product conducted by the U.S. Food and Drug Administration (FDA) revealed the presence of Salmonella.

Production of the product has been suspended while the FDA and the company continue their investigation as to the source of the problem. Consumers who have purchased any of the affected Peppers are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-626-575-7551 between 8am and 4pm PST.

All retailers who receive this product are asked to reconfirm with their distribution centers and all individual stores to ensure that none of the affected Peppers remains in their inventory or at store locations. A separate notification will be forwarded to all relevant customers that received product between March 15th and May 6th 2010. For additional details, retailers are asked to contact their Miravalle Foods, Inc. customer service representative.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica
Posted: July 9, 2010

Contact: Consumer Inquiries – 1(888) 222-6036
Media Inquiries – Bonnie Jacobs
(215) 273-8994 -office
(856) 912-9965 – mobile

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). The risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the January 15, 2010 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions, and information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com1 or call 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). Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.2

The product lot numbers for the recalled products can be found on the side of the bottle label.

FULL RECALLED PRODUCT LIST:

Product Name
Lot Number
UPC Code

BENADRYL® ALLERGY ULTRATAB™
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count
ABA567
312547170338

BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count
ABA574
312547170338

Children’s TYLENOL® Meltaways
CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM 30 count
ABA544
300450519306

MOTRIN® IB
MOTRIN® IB CAPLET 24 count
ACA003
300450481030

MOTRIN® IB CAPLET bonus pack 50+25 count
ACA002
300450481764

MOTRIN® IB TABLET 100 count
AFA060
300450463043

TYLENOL®, Extra Strength
TYLENOL®, Extra Strength EZ TABLET 225 count
ASA206
300450422378

TYLENOL®, Extra Strength EZ TABLET 50 count
ABA005
300450422507

TYLENOL®, Extra Strength COOL CAPLET 24 count
ABA566
300450444240

TYLENOL®, Extra Strength CAPLET bonus pack 24+12 count
ACA025
300450444318

TYLENOL®, Extra Strength CAPLET 50 count
AFA018
300450449078

TYLENOL®, Extra Strength CAPLET 50 count
(included in Day/Night Pack)
ABA168
300450444530

TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530)
AEC005
300450527103

TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530)
AFC005
300450527103

TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count Lot # ABA168 & UPC 300450444530)
ADC002
300450527103

TYLENOL®, Extra Strength RAPID RELEASE GELCAP 24 count
ACA024
300450488244

TYLENOL®, Extra Strength RAPID RELEASE GELCAP 225 count
AJA119
300450488251

TYLENOL® PM
TYLENOL® PM CAPLET 24 count
ACA005
300450482242

TYLENOL® PM CAPLET 24 count
ADA259
300450482242

TYLENOL® PM GELTAB 50 count
AFA100
300450176509

TYLENOL® PM RAPID RELEASE GELCAP 20 count
ACA004
300450244208

Colorado Firm Recalls Bison Products Due to Possible E. Coli O157:H7 Contamination
Posted: July 9, 2010

Recall Release CLASS I RECALL
FSIS-RC-043-2010 HEALTH RISK: HIGH

Congressional and Public Affairs; (202) 720-9113; Atiya Khan

Editor’s Note: This recall release is being reissued to revise the July 2 recall to include approximately 776 additional pounds of bison products that were distributed to a firm in Nevada for further processing.

WASHINGTON, July 7, 2010 – Rocky Mountain Natural Meats, a Henderson, Colo. establishment, is recalling approximately 66,776 pounds of ground and tenderized steak bison products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FSIS became aware of the problem during the course of an on-going investigation into a cluster of E. coli O157:H7 illnesses in Colorado with illness onset dates between June 4, 2010 and June 9, 2010. Working in conjunction with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, the Colorado Department of Public Health and Environment and the New York Department of Health, 5 case-patients have been identified in Colorado as well as 1 case-patient in New York with an indistinguishable PFGE pattern. FSIS determined that there is an association between the ground bison products and the cluster of illnesses in the state of Colorado. FSIS is continuing to work with the CDC, affected state public health partners, and the company on the investigation. Anyone with signs or symptoms of foodborne illness should contact a health care provider.

The following products are subject to recall: [View Labels (PDF Only)]
16-ounce packages of “GREAT RANGE BRAND ALL NATURAL GROUND BISON.” These products have a “sell or freeze by” date of June 21, June 22 or June 24, 2010.
16-ounce packages of “NATURE’S RANCHER GROUND BUFFALO.” These products have a “sell or freeze by” date of June 22, 2010.
16-ounce packages of “THE BUFFALO GUYS ALL NATURAL GROUND BUFFALO 90% LEAN.” These products have a lot number of 0147.
12-ounce packages of “GREAT RANGE BRAND ALL NATURAL BISON STEAK MEDALLIONS.” These products have a “sell or freeze by” date of June 23 and June 24, 2010.
12-ounce packages of “GREAT RANGE BRAND ALL NATURAL BISON SIRLOIN STEAKS.” These products have a “sell or freeze by” date of June 20, June 23 and June 24, 2010.
15-pound boxes of “ROCKY MOUNTAIN NATURAL MEATS, INC. BISON 10 OZ SIRLOIN STEAK.” These products went to restaurants and bear a Julian Code of 0141.
Various weight boxes of “BISON B TRIM.” These products bear a production date of May 21, 2010 and a Julian Code of 14110. The boxes also state “KEEP REFRIGERATED.”

The products subject to recall bear the establishment number “EST. 20247” inside the USDA mark of inspection. These products were produced between the dates of May 21, 2010 through May 27, 2010, and were distributed to retail establishments nationwide, food service distributors in Utah and Arizona, and a firm in Nevada for further processing. While the sell-by dates for these products have passed, FSIS and the establishment are aware that consumers may also freeze the product before use and there is concern that some product may still be frozen and in consumers’ freezers. When available, the retail distribution list(s) will be posted on FSIS’ Website at http://www.fsis.usda.gov/FSIS_Recalls/
Open_Federal_Cases/index.asp.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and in the most severe cases, kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to foodborne illness. Individuals concerned about an illness should contact a physician.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers (including restaurants) of the recall and that steps are taken to make certain that the product is no longer available to consumers.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground bison that has been cooked to a temperature of 160° F. The only way to be sure ground bison is cooked to a high enough temperature to kill harmful bacteria is to use a food thermometer to measure the internal temperature.

Media and consumer questions regarding the recall should be directed to the company’s spokesperson, Chuck Sanger at (800) 325-4164.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at www.AskKaren.gov. “Ask Karen” live chat services are available Monday through Friday from 10:00 a.m. to 4:00 p.m. ET. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.