Month: February 2015

Class II Recall 036-2015
Health Risk: Low Feb 26, 2015

Congressional and Public Affairs
Whitney Joy
(202) 720-9113

 

WASHINGTON, Feb. 26, 2015 – Sunset Farm Foods, Inc., a Valdosta, Ga. establishment, is recalling approximately 42,669 pounds of link sausage products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain hydrolyzed soy protein, a known allergen which is not declared on the product label.

The link sausage items were produced on various dates between September 3, 2014 and January 28, 2015. The following products are subject to recall: [Labels (PDF Only)]

  • 11-lb. vacuum-packed case containing “SOUTHERN CHEF BRAND SMOKED LINK SAUSAGE.”
  • 11-lb. vacuum-packed case containing “GEORGIA MAID SMOKED LINK SAUSAGE.”

The products subject to recall bear the establishment number “EST. 9185” inside the USDA mark of inspection and have a sell-by date between January 1, 2015 and May 28, 2015. These items were shipped to consumers and retail locations in Alabama, Arkansas, Florida, Georgia, New Jersey, and New York.

The problem was discovered by FSIS in-plant personnel during routine label verification.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. (more…)

Contact:
Consumer:
1-800-505-9291

FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots. (more…)

Contact:
Consumer:
(855) 856-9566

FOR IMMEDIATE RELEASE — February 24, 2015 — Fairway “Like No Other Market” of New York, NY, is recalling Fairway brand Raw Hazelnuts (Filberts), because it has 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 Fairway brand Raw Hazelnuts (Filberts) were distributed to Fairway stores in New York, New Jersey and Connecticut, and also through home delivery programs provided by Google and Instacart.

The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. The product bears Item Code 228119 XXXXXX. All “SELL BY” Date codes of May 15, 2015 and earlier are being recalled.

There have been no reported illnesses to date. (more…)

Recall Summary

Name of product: Hand trucks

Hazard:

The wheel hub can separate or break and eject pieces during inflation, posing a risk of injury to the consumer and bystanders.

Consumer Contact: Cosco Home & Office Products toll-free at (888) 250-9299 from 8 a.m. to 5 p.m. ET Monday through Friday, email handtruck@coscoproducts.com  or online at www.coscoproducts.com  and click on Safety Notice at the top of the page for more information.

Report an Incident Involving this Product

Recall Details

Units

About 273,000

Description

This recall involves Cosco Home & Office Products 3-in-1 convertible aluminum hand trucks. The handles can be moved to allow the hand truck to be used in a vertical or horizontal position. Recalled hand trucks have model numbers 12-301 ABL and 12-301 ABL1 and were manufactured from January 2009 to October 2011. The model number and manufacture date are on the Cosco label on the rear side of the bottom cross member.

Incidents/Injuries

Cosco has received 10 reports of wheel hubs separating or breaking and ejecting pieces including four reports of bruises and lacerations. (more…)

Contact:
Consumer:
888-719-8066

Media:
Rebecca Lentz
651-375-5949

FOR IMMEDIATE RELEASE — February 23, 2015 — ARDEN HILLS, MINN. — Purina Animal Nutrition LLC has initiated a limited voluntary recall of DuMOR® Sheep Formula in Florida due to the potential for a higher-than-acceptable level of copper, which can cause health issues and potential mortality. There has been one report of sheep mortality associated with the single lot that is being recalled.

Symptoms of copper toxicity in sheep include: lethargy and anemia, grinding of teeth, thirst, off feed/poor appetite, pale to yellow mucous membranes, red/dark purple colored urine and recumbancy. Death usually occurs one to two days after onset of clinical symptoms.

Customers should discontinue feeding the product immediately. The product was distributed to seven Tractor Supply Company stores in Florida. The recall is limited to DuMOR® Sheep Formula produced at the Lake City, Florida plant on Nov. 28, 2014.

The single lot number is:

Formula No.
Item No.
Description
Lot No.
55EA
0047317
DuMOR® Sheep Formula
4NOV28LKC1

Customers can find the lot number on the sewing strip of each bag. The product was only distributed in Florida.

Retailers have been contacted and told to immediately quarantine any remaining recalled product and notify customers who purchased the product. Customers who purchased this product should return remaining bags to their retailer. (more…)

Recall Summary

Name of product: Sears Kenmore 24-inch electric ranges

Hazard:

The heating element can fail to properly adhere to the cooktop, posing an electrical shock hazard to consumers.

Consumer Contact: Sears toll-free at (888) 281-3915 between 6 a.m. and 10 p.m. CT Monday through Saturday, or between 7 a.m. and 10 p.m. CT Sunday or online at www.sears.com and www.kmart.com and click on Product Recall for more information.

Report an Incident Involving this Product

Recall Details

Units

About 3,000

Description

This recall involves Sears Kenmore 24-inch wide freestanding electric ranges with model number 790.90152 with serial numbers from NF408 through NF424 and model number 790.90153 with serial numbers from NF408 through NF427. The ranges have smooth cooktops and are white or black with stainless steel accents. The model and serial numbers are located on the bottom right frame of the range inside the storage drawer.

Incidents/Injuries

None reported (more…)

Recall Summary

Name of product: Safe Step Walk-In Tubs

Hazard:

The tub’s heated seat can get stuck in the “on” position. If a towel or other item is covering the seat of an empty tub, the seat can overheat, posing a burn hazard to consumers.

Consumer Contact: Oliver Fiberglass toll-free at (888) 492-9423 any time, or online at www.safesteptub.com and click on the Recall link on the Safe Step homepage for more information.

Report an Incident Involving this Product

Recall Details

Units

About 6,400

Description

This recall involves Safe Step walk-in, hydro-massage bath tubs with heated seats.  The recalled tubs have model numbers LP2848, LP2851, LP2853, LP3153 or LP3255 and serial numbers 124423 through 131569 containing the prefix HS, HSHY, HSHS, HSMB or MBHS. The model and serial numbers are located on the back of the small access panel on the faucet end of the tub.

Incidents/Injuries

There have been 11 reports of the empty tub’s heated seat getting stuck in the “on” position, including one report of the seat overheating and becoming hot to the touch. No injuries have been reported. (more…)

Recall Summary

Name of product: Brewmaster Ceiling Fans

Hazard:

The ceiling fan hub holding the blades can separate from the shaft when operating in reverse. If this happens, the fan blades and hub can fall and pose a risk of injury to bystanders.

Consumer Contact: Fanimation Recall Hotline toll-free at (888) 250-6458 from 8 a.m. to 5 p.m. ET Monday through Friday, or visit the firm’s website at www.fanimation.com and click on “Contact Us” for more information. Consumers also can email the firm at recall@fanimation.com.

Report an Incident Involving this Product

Recall Details

Units

9,300

Description

The recall includes Brewmaster belt-driven fans powered by a remote motor. The fans have two blades of various styles and colors, and were sold in a short neck assembly, extending 15 inches from the ceiling and a long assembly extending 26 inches from the ceiling. The fans were sold in antique brass, pewter and black hardware. A face plate on the lower part of the head assembly reads in part, “THE BREWMASTER by FANIMATION.” Fans with the following model numbers on their packaging are included in the recall: FP10AB, FP10AC, FP10BL, FP10PW, FP20AB, FP20AC, FP20BL and FP20PW.

Incidents/Injuries

The firm has received two reports of the ceiling fan hub falling. No injuries have been reported. (more…)

Contact:
Consumer:
(866) 625-1618

FOR IMMEDIATE RELEASE — February 23, 2015 — Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent has transferred the manufacture of this product to its own facility and this product manufactured at the Sagent facility will not be impacted by the recall.

Sagent is not aware of any adverse patient events resulting from the use of the subject product lots. (more…)

Contact:
Consumer:
773-843-0888

FOR IMMEDIATE RELEASE — February 21, 2015 — El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.

El Popocatepetl’s 8in. Flavored Wraps were distributed in the state of Illinois, primarily in the Chicago area.

The information on how the recalled products can be identified is listed below:

Product Name: 8in. Sundried Tomato
Brand Name: El Popocatepetl
Description: 8in. Tomato Flavored Wrap
UPC: 0 20784 99505 7
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Spinach Pest
Brand Name: El Popocatepetl
Description: 8in. Spinach Flavored Wrap
UPC: 0 20784 58314 8
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Chipotle
Brand Name: El Popocatepetl
Description: 8in. Chipotle Flavored Wrap
UPC: 0 20784 78248 0
Any Product with the Best By Date of
April 1, 2015 and Before.

The recall was initiated during a review of the product ingredients and the labeled ingredients revealed milk and Yellow #5 was present in an ingredient used to make the flavored wraps but not listed as ingredients on the labels. No Illnesses have been reported to date. (more…)