Month: August 2018

Class I Recall 072-2018
Health Risk: High Aug 30, 2018

Congressional and Public Affairs
Mitch Adams
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, Aug. 30, 2018 – Publix Super Markets Inc., a Lakeland, Fla., retail grocery store chain is voluntarily recalling an undetermined amount of ground beef products made from chuck that may be contaminated with Escherichia coli O26, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground chuck items were purchased by consumers from June 25, 2018, through July 31, 2018. The following products are subject to recall: https://www.fsis.usda.gov/wps/wcm/connect/330436d0-f5bb-4ee3-a3eb-cca6459bf014/072-2018-List-Products.pdf?MOD=AJPERES&useDefaultText=0&useDefaultDesc=0

These items were shipped to Publix Super Market retail locations in the following Florida counties: https://www.fsis.usda.gov/wps/wcm/connect/68f37b9e-2b95-45c9-8ba7-36500f13a6ac/072-2018-Affected-Counties-Florida.pdf?MOD=AJPERES&useDefaultText=0&useDefaultDesc=0

On Aug. 16, 2018, FSIS was notified of an investigation of E. coli O26 illnesses. FSIS, the Centers for Disease Control and Prevention, and state public health and agriculture partners determined that raw ground chuck was the probable source of the reported illnesses. The epidemiological investigation identified 18 case-patients, predominantly from Florida, with illness onset dates ranging from July 5 to July 25, 2018. Traceback information indicated that case-patients consumed ground chuck products purchased at various Publix Super Markets that was supplied by a yet-to-be determined source. As this investigation further develops, FSIS will continue to work with the supermarket, suppliers and public health partners, and will provide updated information should it become available.

(more…)

For Immediate Release

August 29, 2018

Contact

Consumers

HelloLife, Inc.
 1-616-803- 7243

Announcement

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, HelloLife, Inc. has not received any reports of adverse events related to the recalled products. (more…)

Name of product:
StairMaster® branded 8G Gauntlet Stepmill machines
Hazard:

The steps can accelerate rapidly without input from the user, posing a fall hazard.

Remedy:
Repair
Recall date:
August 30, 2018
Units:
About 3,500
Consumer Contact:

Core Health & Fitness at 800-598-8541 from 6 a.m. to 5 p.m. PT Monday through Friday, email at support@corehandf.com or online at www.corehandf.com and click on “Recall Alert” for more information.

Recall Details

Description:

This recall involves StairMaster branded 8G Gauntlet Stepmill machines with model numbers 9-5250 & 9-5270. The recalled machines were sold in red, black and red/yellow. The recalled machines consist of a revolving staircase and a backlit LCD console. The model number is printed on the base of the unit. The date code is in the YYWW format (1816 means year 2018, week 16).  The date code is the section of the serial number at digits 8 – 11 (see photo). The date code range for SKU 9-5250 is from 1734 to 1823.  The date code range for SKU 9-5270 is from 1813 to 1816. Stairmaster is printed on both sides of the unit and on the shrouds.

Remedy:

Consumers should immediately stop using the recalled exercise machines and contact Core Health & Fitness for a free repair. The firm is contacting all known purchasers directly.

Incidents/Injuries:

The firm has received reports of 52 incidents of steps accelerating unexpectedly, resulting in 12 minor injuries. (more…)

Class I Recall 071-2018
Health Risk: High Aug 29, 2018

Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, Aug. 29, 2018– Olufela Yemitan, the Importer of Record, a Houston, Texas firm, is recalling approximately 45 pounds of smoked Siluriformes products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The dried, smoked Siluriformes items were produced during the month of August 2018. The following products are subject to recall: [View Labels (PDF only)]

  • 1-lb. plastic-wrapped packages of dried, smoked Siluriformes containing “picante fishes spicy catfish smoked with tomatoe pepper sauce ready to eat now!!!!!” and manufacturing date “MFD: 8/2018” and best buy date “BB: 2/2019” on the label.

The products were imported from Nigeria, a country that is not eligible to export Siluriformes to the United States. These items were shipped to retail distribution locations in Texas.

The problem was discovered on August 28, 2018 by FSIS through routine monitoring of eligibility of imported products.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

(more…)

Class I Recall 070-2018
Health Risk: High Aug 29, 2018

Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, Aug. 29, 2018 – Taylor Farms Illinois, Inc., a Chicago, Ill. establishment, is recalling approximately 75 pounds of beef and pork meatloaf products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains eggs and wheat, known allergens, which are not declared on the product label.

The beef and pork meatloaf was produced on August 22, 2018. The following products are subject to recall: [View Labels (PDF only)]

  • 14-oz. plastic tray packages containing ready-to-eat “HOMESTYLE BEEF AND PORK MEATLOAF” with lot code “TFIL234A001” and a “USE-BY: 08/28/18” date on the label.

The products subject to recall bear establishment number “EST. 21794” inside the USDA mark of inspection. These items were shipped to retail locations in Alabama, Arkansas, Kentucky, Mississippi, Ohio and Tennessee.

The problem was discovered on August 27, 2018, by a retail store employee, who then reported the issue to the firm.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

(more…)

For Immediate Release

August 28, 2018

Contact

Consumers

Kathryn Weingart
Vice President Quality & Regulatory Affairs
 1-704-939-4342

Announcement

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. This recall should be carried out to the retail level.

Risk Statement: Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, including babies or very young children. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date. (more…)

Name of product:
Reptile strip light fixtures
Hazard:

The strip light’s fluorescent bulb can overheat causing the hood on the light fixture to ignite, posing a fire hazard.

Remedy:
Refund
Recall date:
August 30, 2018
Units:
About 23,000 (in addition, about 440 were sold in Canada)
Consumer Contact:

PetSmart toll-free at 888-839-9638 from 8 a.m. to 5 p.m. MT Monday through Friday or online at www.petsmart.com and click on “Recalls” for more information.

Recall Details

In Conjunction With:
Description:

This recall involves 20 inch and 30 inch All Living Things reptile strip light fixtures. These light fixtures simulate natural daylight and are attached to the top of the reptile’s terrarium.  The 20 inch fixture has UPC number 73725773305 and the 30 inch fixture has UPC number 73725773306 printed on the packaging.

Remedy:

Consumers should immediately stop using the recalled light fixtures and return them to any PetSmart store for a full refund.

Incidents/Injuries:

 PetSmart has received six reports of the hood on the recalled light fixtures igniting. (more…)

For Immediate Release

August 24, 2018

Contact

Consumers

Living Well Remedies, LLC
CustomerCare@LivingWellRemedies.com
800-249-7705

Announcement

FOR IMMEDIATE RELEASE – Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. Living Well Remedies, LLC has n (more…)

For Immediate Release

August 27, 2018

Contact

Consumers

Mr. Trung S.Tran
 (718) 417-9281

Media

Jola Szubielski
Kirstan Conley
 Jola.Szubielski@agriculture.ny.gov
 Kirstan.Conley@agriculture.ny.gov
 518-457-0752

Announcement

New York State Agriculture Commissioner Richard A. Ball today alerted consumers that the “Lily Bulb” product (photo attached) distributed by Allied Imports Inc. of 267 52nd Street, Brooklyn, NY 11220 was found to contain sulfites, which are not declared on the product label.  People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. No illnesses have been reported to date to this Department in connection with this product. (more…)

For Immediate Release

August 27, 2018

Contact

Consumers

 1-855-869-1081

Announcement

Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to this recall. (more…)