Month: January 2018

Class I Recall 005-2018
Health Risk: High Jan 23, 2018

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

 

WASHINGTON, January 23, 2018 – Perdue Foods LLC, a Monterey, Tenn. establishment, is recalling approximately 530 pounds of chicken 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, a known allergen which is not declared on the product label.

The ready-to-cook chicken breast tenderloin fritters were inadvertently labeled with the Homestyle Chicken Tender Fritter label. The chicken breast tenderloin fritters contain egg whites and the Homestyle Chicken Tender Fritters do not. The ready-to-cook chicken tenderloin fritter items were produced on December 6, 2017. The following products are subject to recall: [View Label]

  • 10-lb. boxes containing two 5 lb. plastic bags with the box labeled “CHEF REDI HOMESTYLE CHICKEN TENDER FRITTER, RTC – LARGE” with the case code of 7374.

The products subject to recall bear establishment number “P-11507” inside the USDA mark of inspection. These items were shipped to food service locations in Florida, Maryland and Washington D.C.

The problem was discovered by the firm while performing routine label verification activities.

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…)

Name of product:
SYLVANIA recessed canister light kits
Hazard:

The recalled recessed canister light kits can short circuit, posing a shock and electrocution hazard when consumers try to troubleshoot flickering lights.

Remedy:
Replace
Recall date:
January 31, 2018
Units:
About 45,000 in the U.S. (In addition, about 11,000 were sold in Canada)
Consumer Contact:

LEDVANCE at 800-654-0089 from 8 a.m. to 6 p.m. ET Monday through Friday or www.SYLVANIA.com and click on “Legal” and then “Recalls” for more information.

Recall Details

Description:

This recall involves SYLVANIA RT56HO 900 lumen recessed canister light kits with Batch 0 following a five digit code, for example 75137-0, printed on the back of the white rim and on the product’s packaging.

 

Model number  Product Description
75137-0 LEDRT56HO900827 2/CS 1/SKU
75138-0 LEDRT56HO900830 2/CS 1/SKU
75139-0 LEDRT56HO900840 2/CS 1/SKU
75140-0 LEDRT56HO900835 2/CS 1/SKU
Remedy:

Consumers should immediately stop using the recalled canister light kits and contact the firm for free replacement and installation by a technician. Warnings and instructions must be followed to disconnect power prior to servicing, removing or replacing the recalled products.

Incidents/Injuries:

LEDVANCE has received three reports of consumers being shocked by the recalled canister lights. No injuries have been reported. (more…)

Name of product:
Sunny CS (cribside) nursery space heaters
Hazard:

A broken motor mount can allow the electric heating element to come in contact with the interior plastic materials and ignite, posing fire and burn hazards.

Remedy:
Replace
Recall date:
January 31, 2018
Units:
About 5,000 in the U.S. (In addition, about 100 were sold in Canada.)
Consumer Contact:

Contact Vornado toll-free at 844-202-7978 from 8 a.m. to 5 p.m. CT Monday through Friday or online at www.vornado.com and click on the recall graphic in the lower right corner of the homepage for more information.

Recall Details

In Conjunction With:
Description:

This recall involves Vornado Sunny CS (cribside) model EH1-0090 electric space heaters. They were sold in white with an accent of melon and gray colors. The heaters measure approximately 12 inches high, 8 inches deep and 11 inches at the base. The controls are mounted in a soft touch panel on the top of the unit with a multi-color display in the center of the control panel. “Vornadobaby” is printed on the side of the heater. The Vornado logo is printed on the front center of the unit. The model/type “SUNNY CS EH1-0090” and serial number are printed on a silver decal on the bottom of the unit under the elastic cord wrap. The recalled heaters have the numbers 1 and 7 as the fourth and fifth digits of the serial number (XXX17-XXXXXX).

Remedy:

Consumers should immediately stop using the recalled space heaters, unplug them and contact Vornado for instructions on how to receive a free replacement unit, including free shipping.

Incidents/Injuries:

Vornado has received five reports of the electric heaters catching on fire. No injuries or property damage have been reported. (more…)

Name of product:
Well at Walgreens pain and itch relief cream
Hazard:

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain and itch relief cream contains lidocaine, posing a risk of poisoning to young children.

Remedy:
Refund
Recall date:
January 30, 2018
Units:
About 74,000
Consumer Contact:

Natureplex toll-free at 866-323-0107 from 9 a.m. to 5 p.m. CT Monday through Friday or online at www.natureplex.com and click on Product Safety Recall for more information.

Recall Details

Description:

The recalled Well at Walgreens Pain and Itch Relief Cream tube and packaging are orange with a purple stripe with “Maximum Strength,” “Pain and Itch Relief Cream 4% Lidocaine” and “NET WT 2 OZ (56.7 grams)” printed in white on the front. The Well at Walgreens logo is located on the front upper right corner. The  packaging contains the UPC bar code 3 11917 18962 8 on the back.

Remedy:

Consumers should immediately place the recalled pain and itch relief cream out of the reach of children and return it to Walgreens for a full refund.

Incidents/Injuries:

None reported (more…)

For Immediate Release

January 28, 2018

Contact

Consumers

 1-855-6-PANERA

Media

Jonathan Yohannan
jonathan.yohannan@panerabread.com

Announcement

While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative. (more…)

For Immediate Release

January 26, 2018

Contact

Consumers

 (480) 483-1410

Announcement

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

Between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.

Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel.  It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA’s health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested. (more…)

For Immediate Release

January 28, 2018

Contact

Consumers

 1-855-6-PANERA

Media

Jonathan Yohannan
jonathan.yohannan@panerabread.com

Announcement

While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative. (more…)

For Immediate Release

January 25, 2018

Contact

Consumers

Customer Support
  support@bulletproof.com
 (877) 651-9482

Announcement

Out of an abundance of caution, Bulletproof 360, Inc. is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to undeclared milk.  People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

The recalled product is Bulletproof Collagen Protein dietary supplement, packaged in a 16-oz. composite-film bag and has the UPC 8 15709 02115 3.  The affected lot #1017088 EXP03/19 is found on the back panel of a bag, and EXP03/19 means expires by March 2019.  All other lots of Bulletproof Collagen Protein and other products purchased at bulletproof.com are not affected by this recall.

Affected Bulletproof Collagen Protein was sold directly to distributors in CA, CO, CT, FL, GA, IA, IN, NH, NY, OR, PA, SC, TX, WA, WI and product has been further distributed to retail stores nationwide.

This voluntary recall was initiated after we discovered that bulk whey (milk) protein was mis-labeled as collagen protein by our third-party manufacturer during the manufacturing process.  As a result, the affected Bulletproof Collagen Protein product contains the whey (milk) protein and the finished product label does not declare milk. (more…)

Name of product:
Lights & Lullabies travel mobiles
Hazard:

The clamp attaching the mobile to the crib rail can break causing the mobile to fall, posing an injury hazard to an infant in the crib.

Remedy:
Refund
Replace
Recall date:
January 25, 2018
Units:
About 37,000 in the U.S. (In addition, 4,800 were sold in Canada.)
Consumer Contact:

VTech at 800-521-2010 from 8 a.m. to 7 p.m. CT Monday through Friday or online at vtechkids.com and click on Support for more information or register online at https://www.vtechkids.com/support/support_form.

Recall Details

In Conjunction With:
Description:

This recall involves VTech Lights & Lullabies Travel mobiles. The recalled mobiles were sold in blue and pink. The model numbers are 80-503000 (blue) and 80-503050 (pink). The pink mobile was sold exclusively at Amazon.com. The mobile has a white and pink or white and blue plastic arm that clamps onto the side of a crib. It has three star attachments that hang from the top. The mobile has a music button that plays music, nature sounds and nursery rhymes. The mobile measures 5 inches wide by 15.8 inches tall.The model numbers are printed on the battery compartment door.

Remedy:

Consumers should immediately stop using the recalled mobiles and contact Vtech for a full refund or a replacement product.

Incidents/Injuries:

Vtech has received six reports of the clamp cracking. No injuries have been reported. (more…)

Name of product:
Elkay and Halsey Taylor water coolers and bottle filling stations
Hazard:

Internal screws that secure the grounding wire can break and allow the grounding wire to become loose, posing a shock hazard.

Remedy:
Repair
Recall date:
January 25, 2018
Units:
About 31,600
Consumer Contact:

Elkay toll-free at 866-243-3070 Monday through Friday from 7 a.m. to 4 p.m., email at Recall17@elkay.com or online at www.elkay.com and click on PRODUCT RECALL for more information. Consumers can also go to www.checkmycooler.com and enter a unit’s full serial number to see if it is included in the recall.

Recall Details

Description:

This recall involves Elkay and Halsey Taylor water coolers and bottle filling stations with the model numbers that begin with the letter and number combinations listed below. They are mainly installed in public facilities such as schools/universities, office buildings and airports. The brand Elkay or Halsey Taylor is identified on the front of the units with a nameplate or embossing and the affected serial numbers begin with the numbers 1704, 1705 or 1706. For more information on where to identify the model numbers and serial numbers on the units, visit www.checkmycooler.com .

 

Elkay Models
ECP8, ECU8
EFA(4, 8, 14, 16, 20)
EFHA(8, 14)
EFOA8
EFY8
EHFSA8
EMABF(TL)8
ESWA8
EW(TL)A(4, 8, 14, 16, 20)
EWCA(4, 8, 14)
EZ (all models)
FD700(3, 5, 10)
HEW3
LFAE(8, 14, 20)
LFDE10
LMABF(TL)8
LVRC(TL)8
LVRCGRN(TL)8
LVRCHD(TL)8
LWAE(8, 14)
LWCE4
LZ (all models)
OHFAVR8
VRC(TL)8, VRC(TL)FR(D, 8)
VRCGRN(TL)8
VRCHD(TL)8

 

Halsey Taylor Models
HAC(G)8
HBW8
HOF14
HTHBHAC(G)8
HTHBHVR8
HTVZ (all models)
HVR(GRN)8
HVR8HD
S(300, 500, 10000)
SCWT(8, 14, 20)
SW(4, 8, 14)
WC8
WM(8, 14, 16)
XP8

 

 

Remedy:

Consumers should immediately stop using the recalled water coolers and bottle filling stations, unplug the units and contact Elkay for a free repair.

Incidents/Injuries:

The firm has received 362 reports of broken screws being found in units prior to installation. No injuries have been reported. (more…)