Month: August 2016

For Immediate Release

August 26, 2016

Contact

Consumers

Stericycle
1-866-300-2207

Media

Mark Donohue
1-215-558-4526

Announcement

Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company had issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg. The Company is issuing this press release to provide further heightened awareness of this recall and to provide instructions to consumers, pharmacists, and wholesalers in possession of the affected product. Details related to the recalled product are set forth below.

NDC Number Blister Pack Lot Number
0115-1529-08 30 502240

Unit-of-use blister packs (a 10 count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of 200 mg product. Each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT, however the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT. Shell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose.

Lamotrigine is indicated for the treatment of epilepsy or bipolar disorders. It is important for consumers to take the dose of lamotrigine prescribed by their physicians. A reduction in dose may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.

The affected lot was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer’s carton as well as on the blister cards within the unit-of-use blister packs. Lamotrigine ODT 200 mg tablets are off-white to white circular tablets, approximately 14 mm in diameter, debossed with “WPI” on one side and “3724”on the other, supplied in blisters of 10 (NDC 0115-1529-15) and in cartons of 30 (NDC 0115-1529-08). (more…)

For Immediate Release

August 26, 2016

Contact

Consumers

Country Fresh, Inc.
 281-453-3305

Announcement

August 26, 2016.  Country Fresh, LLC. of Conroe, Texas, is recalling 30,000 cases of various fresh-cut vegetable products (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The product in question was shipped to retailers in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia under the Country Fresh and store brand labels described in the product listing.

The product bears “BEST IF USED BY” dates between August 7, 2016 (8/7/16) through August 19, 2016 (8/19/16).  The product is in either a clear plastic container as labeled below or in Styrofoam trays overwrapped with clear plastic film as labeled below.  No products except those on this list are subject to this recall.

To date, no illnesses have been confirmed by public health authorities. (more…)

Class I Recall 075-2016
Health Risk: High Aug 26, 2016

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

 

WASHINGTON, Aug. 26, 2016 – WFSP Foods LLC, a Decatur, Ala. establishment, is recalling approximately 18,672 pounds of pork and chicken sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen which is not declared on the product label.

The ready-to-eat sausage items were produced on June 7, 2016. The following product is subject to recall: [View Labels (PDF Only)]

  • 13.5-oz. packages containing “Land O’ Frost Simply Savory Bacon & Cheddar Smoked Sausage” with a “BEST BY: DEC. 04 2016” and packaging date of 06/07/16.

The product subject to recall bears establishment number “EST. 45411” printed on the packaging. This item was shipped to retail locations nationwide.

The problem was discovered in a retail store by a company representative and immediately reported to FSIS. The product has the correct label on the front of the package, which identifies that the product contains cheese. However, the label in the back fails to include cheddar cheese as an ingredient – the source of milk. As a result, milk is not included in the ingredients statement or in the “Contains” allergen declaration.

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 26, 2016

Contact

Consumers

Country Fresh, Inc.
 281-453-3305

Announcement

August 26, 2016.  Country Fresh, LLC. of Conroe, Texas, is recalling 30,000 cases of various fresh-cut vegetable products (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The product in question was shipped to retailers in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia under the Country Fresh and store brand labels described in the product listing.

The product bears “BEST IF USED BY” dates between August 7, 2016 (8/7/16) through August 19, 2016 (8/19/16).  The product is in either a clear plastic container as labeled below or in Styrofoam trays overwrapped with clear plastic film as labeled below.  No products except those on this list are subject to this recall.

To date, no illnesses have been confirmed by public health authorities. (more…)

For Immediate Release

August 25, 2016

Contact

Consumers

Willis Ocean Inc.
 1-718-386-3053

Announcement

Willis Ocean Inc. of Brooklyn, NY, is recalling 30 cases of Willis Eagle brand MUT GUNG SWEETENED GINGER, because it contains undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

Willis Eagle brand MUT GUNG SWEETENED GINGER, Net Weight 7 oz. (200g), was distributed from May 2012 through July 2016 to retail stores throughout the state of Florida.

The product is packaged in round, clear plastic containers with the title label on the top lid and the ingredient label and UPC 8935129760691 on the bottom of the container. The product was imported from Vietnam.

No illnesses have been reported to date. (more…)

Class II Recall 074-2016
Health Risk: Low Aug 25, 2016

Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, Aug. 25, 2016 – Sentry Foods, a Tucker, Ga. establishment, is recalling approximately 21,570  pounds of frozen chicken entrées  that may be contaminated with extraneous materials, specifically glass or hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen chicken entrée items were produced and packaged on March 17, March 18, April 30, and May 13, 2016. The following products are subject to recall: [View Labels (PDF Only)]

  • 10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “08-19-2017” and lot number 0219-00207-016.
  • 10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “10-29-2017” and lot number 0429-00258-016.
  • 10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “10-29-2017” and lot number 0429-00207-016.

The products subject to recall bear establishment number “EST. P-19031” inside the USDA mark of inspection or printed on the side of the container. These items were shipped to retail locations in Indiana, Texas, and Pennsylvania.

The problem was discovered through consumer complaints reported to the company who then contacted FSIS. No injuries were reported with the complaints. (more…)

Class II Recall 073-2016
Health Risk: Low Aug 24, 2016

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

 

WASHINGTON, Aug. 24, 2016 – Green Bay Dressed Beef, LLC, doing business as American Foods Group, LLC, a Green Bay, Wis. establishment, is recalling approximately 7,420 pounds of beef brain products that may be contaminated with specified risk materials (SRM) the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The beef brains were produced on various dates between April 24, 2016, and August, 11, 2016. The following products are subject to recall: [View Label (PDF Only)]

  • 15-unit cases containing beef brains labeled “AMERICAN FOODS GROUP BEEF BRAINS <30” and bearing packaging code 06400.

The products subject to recall bear establishment number “EST. 410” inside the USDA mark of inspection. These items were shipped to a distributor in California.

The problem was discovered while FSIS inspectors were conducting verification activities.

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

Recall Summary

Name of product: Cree® LED T8 Replacement Lamps

Hazard:

The recalled lamps can overheat and melt, posing a burn hazard.

Consumer Contact: Cree toll-free at 888-338-7883 from 8 a.m. to 5 p.m. CT Monday through Friday, email at T8Rledlamps@cree.com or online at www.cree.com and click on “Recalls” for more information.

Report an Incident Involving this Product

Recall Details

In conjunction with

Canada Flag

Units

About 104,000 in the U.S. (in addition, 8,500 were sold in Canada)

Description

This recall involves Cree LED T8 Replacement Lamps, including lamps that were provided as free replacements for a previous recall in June 2015 and new lamps sold since the recall. These lamps are used indoors to replace traditional two-pin T8 fluorescent tubes. The white lamps have a cylindrical shape and measure 48 inches long. “Cree,” “BT848 Series Lamp,” the product number and a four-digit date code are printed on the lamp or on a white label affixed to the lamp.

 

Product Number Lamp Description   Date Codes
BT848-17027FLW-BDG13-2C100 Linear LED T8 Replacement Lamp, 4 Ft, 1700 Lm, 2700K, 1-pack, US  

 

06/15

07/15

08/15

09/15

10/15

11/15

12/15

01/16

02/16

03/16

04/16

05/16

BT848-17040FLW-BDG13-2C100 Linear LED T8 Replacement Lamp, 4 Ft, 1700 Lm, 4000K, 1-pack, US
BT848-17027FLW-BDG13-2C120 Linear LED T8 Replacement Lamp, 4 Ft, 1700 Lm, 2700K,10-pack, US
BT848-17040FLW-BDG13-2C120 Linear LED T8 Replacement Lamp, 4 Ft, 1700 Lm, 4000K, 10-pack, US

 

Incidents/Injuries

Cree has received 12 reports of the recalled lamps overheating and melting. No injuries have been reported. (more…)

Recall Summary

Name of product: M&M’S®-branded jewelry

Hazard:

The jewelry can contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health issues.

Consumer Contact: M&M’S World at 866-915-5058 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.mmsworld.com and click on the “Product Safety & Recalls” link at the bottom of the page for more information.

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Recall Details

Units

About 52,400

Description

This recall involves all M&M-branded jewelry, including some children’s jewelry. Recalled items include earrings, rings, bracelets and necklaces sold between May 2015 and July 2016. Jewelry items included in the recall have the M&M’S logo “M” as a charm or other feature.

Incidents/Injuries

No injuries or incidents have been reported in connection with these products. (more…)

Recall Summary

Name of product: Whirlpool brand microwave hood combinations

Hazard:

Internal arcing during use can ignite an internal plastic component, posing a fire hazard.

Consumer Contact: Whirlpool Corporation at 800-990-6254 from 8 a.m. to 8 p.m. ET Monday through Friday, or online at http://repair.whirlpoolcorp.com. Consumers can also visit www.whirlpool.com and click on “Product Recall” for more information.

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Recall Details

Units

About 15,200

Description

This recall involves Whirlpool brand microwave hood combinations. The microwave ovens were sold in stainless steel, black and white. Model numbers and serial numbers are located on the inside of the unit, above the oven cavity on the left hand side. The following model and serial numbers are included in the recall:

 

Model Numbers Serial Numbers
WMH53520CS TR33500000 to TR34899999 
WMH53520CW  TR33500000 to TR34899999 
WMH53520CB  TR33500000 to TR34899999
WMH53520CE TR33500000 to TR34899999
WMH53520CH TR33500000 to TR34899999
WMH73521CS TR33500000 to TR34899999
WMH73521CW TR33500000 to TR34899999
WMH73521CB TR33500000 to TR34899999
WMH73521CE TR33500000 to TR34899999
WMH73521CH TR33500000 to TR34899999

 

A complete list of model and serial numbers included in this recall is posted on the firm’s website at http://repair.whirlpoolcorp.com.

Incidents/Injuries

Whirlpool has received five reports of incidents, including one home fire, two fires involving the surrounding cabinets, one report of smoke, and one report of a burning odor. (more…)