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Recent Agency News

Recall of Infants’ Ibuprofen:

12/7/2018

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed below:

1. Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
WAL-MART Stores
2. CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
CVS Pharmacy
3. Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle
Family Dollar Services

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.



 

RECALL: Cap’n Crunch’s Peanut Butter Crunch

11/27/2018

The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best Before Dates, Quaker is initiating the voluntary recall to protect public health.

The recall was initiated as the result of a routine sampling program by the company, which revealed the finished product may contain bacteria. Salmonella is 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.

The product being recalled was distributed in limited quantities only to the five Target stores listed below. This recall only includes 21 outstanding boxes purchased after Nov 5:

17.1 ounce boxes of Cap’n Crunch’s Peanut Butter Crunch cereal with UPC code 0 30000 6211 1 and Best Before Dates of JUL 30 19 or JUL 31 19 purchased at the following Target stores:

Super Target 4001 N 132nd St Omaha NE 68164
P-Fresh 4250 Rusty Rd Saint Louis MO 63128
Super Target 10800 E 21st St N Wichita KS 67206
Super Target 8201 S 40th St. Lincoln NE 68516
P-Fresh 1040 NE Coronado Blue Springs MO 64014

Consumers who have purchased the above products are advised not to consume them, and urged to dispose of or return them to the place of purchase for a full refund. They can direct any questions to 800-234-6281 , Monday – Friday, 8:30 a.m. – 5:00 p.m. (EST), or find more information at cu.pepsico.com/capncrunch



 

RECALL: Jennie-O Turkey

11/19/2018

Jennie-O Turkey Store Sales, LLC, a Barron, Wis. establishment, is recalling approximately 91,388 pounds of raw ground turkey products that may be associated with an illness outbreak of Salmonella Reading, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground turkey products items were produced on September 11, 2018. The following products are subject to recall: [View Labels (PDF only)]

• 1-lb. packages of "Jennie-O GROUND TURKEY 93% LEAN | 7% FAT" with "Use by" dates of 10/01/2018 and 10/02/2018.
• 1-lb. packages of "Jennie-O TACO SEASONED GROUND TURKEY" with a "Use by" date of 10/02/2018.
• 1-lb. packages of "Jennie-O GROUND TURKEY 85% LEAN | 15% FAT" with a "Use by" date of 10/02/2018.
• 1-lb. packages of "Jennie-O ITALIAN SEASONED GROUND TURKEY" with a "Use by" date of 10/02/2018.

The products subject to recall bear establishment number “P-190” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

FSIS, the CDC, and state public health and agriculture partners, have been working together on an illness cluster involving 164 case-patients in 35 states. Patients have reported eating different types and brands of turkey products purchased from many different stores, handling raw turkey pet food and/or raw turkey, or working with live turkeys or living with someone who handled live turkeys. FSIS continues to work with the CDC and state health departments on this investigation and will provide updated information as it becomes available. Based on the continuing investigation, additional product from other companies may also be recalled.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume raw poultry product that has been cooked to a temperature of 165°F. Safe steps in food handling, cooking, and storage are essential in preventing foodborne illness. You can't see, smell, or taste harmful bacteria that may cause illness. In every step of food preparation, follow the four guidelines to keep food safe:
• Clean—Wash hands and surfaces often.
• Separate—Separate raw meat from other foods.
• Cook—Cook to the right temperature.
• Chill—Refrigerate food promptly

Consumers with questions regarding the recall can contact Jennie-O Consumer Engagement Team at 1-800-621-3505 , 8 a.m. – 4 p.m. Central Time Monday – Friday and 9 a.m. – 5 p.m. Central Time Saturday and Sunday. Media with questions can contact media@hormel.com or 507-434-6352.



 

Recall Notice...Frito-Lay

11/8/2018

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled Smartfood Delight Sea Salt Flavored popcorn bags.

The products covered by this recall were distributed in retail locations in the following states: Alabama, Arkansas, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming. The recalled products were also distributed through e-commerce websites.

No illness related to this matter has been reported to date.

The recalled products are 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn packaged in the following variety pack offerings which have "use by" dates and 11-digit manufacturing codes printed on the outer packaging as listed below:
• 16 count Smartfood Delight Variety Pack Sack – "use by" dates of 4 DEC 2018 OR 18 DEC 2018, and 11-digit manufacturing code that will include the letter combination AM in the second and third position (example: xAMxxxxxxxx)

• 16 count Crunch & Pop Mix Variety Pack Sack – "use by" dates of 18 DEC 2018 OR 1 JAN 2019, and 11-digit manufacturing code that will include the letter combination AM in the second and third position (example: xAMxxxxxxxx)

In addition, the individual recalled 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn have a "guaranteed fresh" date of 1 JAN 2019 and a 9-digit manufacturing code of 615325107 printed on the front upper panel. No other products or flavors contained in these variety packs are being recalled

Consumers with any of the above recalled products should contact Frito-Lay Consumer Relations at 1-800-352-4477 (9 a.m. – 4:30 p.m. CST, Monday-Friday) for reimbursement.



 

RECALL NOTICE...DUNCAN HINES

11/6/2018

Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.

The products covered by this recall were distributed for retail sale in the U.S. and limited international exports; the specific product information is listed below. No other Duncan Hines products or Conagra Brands’ products are impacted by this recall.

Product Description & Brand & Product UPC Best If Used By Date (located on top of box)

Duncan Hines Classic White Cake 15.25oz. 644209307500 MAR 7 2019 MAR 8 2019 MAR 9 2019 MAR 10 2019 MAR 12 2019 MAR 13 2019

Duncan Hines Classic Yellow Cake 15.25oz. 644209307494 MAR 9 2019 MAR 10 2019 MAR 12 2019 MAR 13 2019

Duncan Hines Classic Butter Golden Cake 15.25oz. 644209307593 MAR 7 2019 MAR 8 2019 MAR 9 2019

Duncan Hines Signature Confetti Cake 15.25oz. 644209414550 MAR 12 2019 MAR 13 2019

Consumers who have purchased these items are advised not to consume them and to return them to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Care team at 1-888-299-7646.



 
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