Month: August 2015

Class I Recall 117-2015
Health Risk: High Aug 31, 2015

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

 

WASHINGTON, Aug. 31, 2015 – Ocho Rios, a Miami, Fla. establishment, is recalling approximately 7,228 pounds of canned corned beef produced in Brazil 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. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The canned corned beef was imported on August 7, 2015. The following products are subject to recall: [View Labels (PDF Only)]

  • 18-lb. packages containing 24- 12 oz. cans of “Corned Beef with Juices.”

The products subject to recall bear establishment number “Brasil 226 S.I.F.” inside the mark from Brazil’s Ministry of Agriculture. The cases of products contain the shipping mark “BT/7100366 MIAMI” and the can codes “16952U,” “16951U,” “15251U,” or “15252U.” These products were shipped to retail locations in Fla. and one distribution center in Ga. to be further distributed.

The problem was discovered by FSIS personnel during routine failure to present surveillance activities.

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

Class I Recall 116-2015
Health Risk: High Aug 28, 2015

Congressional and Public Affairs
Katherine Scheidt
(202) 720-9113

 

WASHINGTON, Aug. 28, 2015 – Real Foods, a Kent, Wash. establishment, is recalling approximately 41 pounds of chicken wrap products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, and sulfites, which are not declared on the product label.

The chicken wrap items were produced on August 25, 2015. The following product is subject to recall: [Labels (PDF Only)]

  • 9.5-oz. plastic tray packages containing a “Kung Pao-Style Chicken Wrap” with a sell-by date of 8/29/2015.

The products subject to recall bear establishment number “P-34834” inside the USDA mark of inspection. These items were shipped to retail locations in Washington.

The problem was discovered when a retail store noticed that the back label mistakenly listed the chicken wrap as a “Turkey Pesto Wrap” and included the wrong ingredient list.

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…)

Class III Recall 115-2015
Aug 27, 2015

Congressional and Public Affairs
Felicia Thompson
(202) 720-9113

 

WASHINGTON, Aug. 27, 2015 – Swanson Meats, a Minneapolis, Minn., establishment, is recalling approximately 20,063 pounds of beef products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were formulated with soybean oil, MSG, and papain (a meat tenderizer), which were not declared on the product labels. Soy is a known allergen. MSG may cause allergy-type reactions to those who may have sensitivity to it.

The boneless beef tender tips were produced on various dates from Feb. 26, 2015 through Aug. 26, 2015. The following products are subject to recall:

  • 20-lb cases of “Marinated Boneless Beef Tender Tip” bearing case code “SM04291” and establishment number “Est. 5697” inside the USDA mark of inspection.

These items were shipped to restaurants in Minneapolis and St. Paul. The problem was discovered by FSIS in-plant personnel during routine inspection activities.

FSIS and the company have received 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 110-2015 expansion
Health Risk: High Aug 27, 2015

Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113

 

EDITORS NOTE: This release is being reissued to expand the August 13, 2015 recall to include additional products. Details of this release were also updated to reflect a change in poundage, epidemiological informational and distribution area.

 

WASHINGTON, Aug. 27, 2015 – Kapowsin Meats, a Graham, Wash. establishment, is recalling approximately 523,380 pounds of pork products that may be contaminated with Salmonella I 4,[5],12:i:-, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

FSIS has been conducting intensified sampling at Kapowsin Meats while this establishment took steps to address sanitary conditions at their facility after the original recall on August 13, 2015. Sampling revealed positive results for Salmonella I 4,[5],12:i:- on Whole Hogs for Barbeque, associated pork products and throughout the establishment. FSIS has deemed sanitary improvement efforts made by the Kapowsin Meats insufficient, and the scope of this recall has been expanded to include all products associated with contaminated source material. The establishment has voluntarily suspended operations.

The whole hogs and associated items were produced on various dates between April 18, 2015 and August 26, 2015. The following products are subject to recall: [View Labels (PDF Only)]

  • Varying weights of boxed/bagged Whole Hogs for Barbeque
  • Varying weights of boxed/bagged fabricated pork products including various pork offal products, pork blood and pork trim.

The product subject to recall bears the establishment number “Est. 1628” inside the USDA mark of inspection. The product was shipped to various individuals, retail locations, institutions, and distributors in Alaska, Oregon and Washington.

On July 15, 2015, the Washington State Department of Health notified FSIS of an investigation of Salmonella I 4,[5],12:i:- illnesses. Working in conjunction with the Washington State Department of Health and the Centers for Disease Control and Prevention (CDC), FSIS determined that there is a link between whole hogs for barbeque and pork products from Kapowsin Meats and these illnesses. Traceback investigation has identified 36 case-patients who consumed whole hogs for barbeque or pork products from this establishment prior to illness onset. These illnesses are part of a larger illness investigation. Based on epidemiological evidence, 152 case-patients have been identified in Washington with illness onset dates ranging from April 25, 2015 to August 12, 2015. FSIS continues to work with our public health partners on this ongoing investigation. (more…)

Contact:
Consumer:
1-855-407-3729

FOR IMMEDIATE RELEASE – August 27, 2015 – Billerica, MA – On July 8, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet’s current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).

There are two ways in which these Pods can fail at a rate that is higher than Insulet’s current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).

The affected Pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.

Please check to determine if you have Pods from any of the lots listed below. The lot number is located on the Pod tray lid label and is also laser etched on the side of each individual Pod. The lot number is also located on the box of OmniPods. Consumers who have Pods from the affected lots should stop using them and return the pods for replacement.

The following OmniPod lots have been voluntarily recalled:

Distribution Catalog Number Description Lot Number
United States POD-ZXP420 OmniPod® Insulin Management System L40806
L40811
L40895
L40976
L41014
L41025
L41067
L41162
L41171
L41197
L41198
L41250
International 14810 OmniPod® Insulin Management System L40771
L40892
L40901
L40905
L40997
L41199
L41208

OmniPods from the affected lots were distributed to customers from December 2013 to March 2015.

Insulet has notified its distributors and customers by email, FedEx, and phone calls and is arranging for return and replacement of all recalled product. Consumers with questions may contact the Company via telephone at 1-855-407-3729 at any time. (more…)

Contact:
Consumer:
(305)947-6244 or
email theoneminutemiracle@gmail.com

FOR IMMEDIATE RELEASE – August 27, 2015, North Miami Beach, Florida – The One Minute Miracle Inc. is voluntarily recalling one lot each of Miracle Diet 30, capsules and Miracle Rock 48.

Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity. There is a reasonable probability that the health risks of long term phenolphthalein consumption could include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long term use.

Miracle Diet 30 capsules is marketed as a dietary supplement to support appetite control and lose weight and is packaged in 30-count plastic bottles. The affected Miracle Diet 30 Lot Number 150416, Expiration 04/15/2018. Product was distributed via internet nationwide in the United States.

Miracle Rock 48 has been found to contain undeclared thiosildenafil, thiosildenafil is an analogue of sildenafil which is an approved drug used for the treatment of male sexual enhancement. Based on the similarity of chemical structures thiosildenafil, the analogue of sildenafil is likely to have a similar pharmacological effect as sildenafil and there is a reasonable probability that concomitant use of this dietary supplement and nitrates could cause a sudden and significant drop in blood pressure that may be life threatening.

Miracle Rock 48 is capsules is marketed as a dietary supplement for male sexual enhancement and is packaged in two blister packages of 2-count capsules, 4 capsules per box. The affected Miracle Rock 48 Lot Number 20150602, Expiration 06/01/2018. Product was distributed via internet nationwide in the United States.

These undeclared ingredients make Miracle Diet 30 and Miracle Rock 48 unapproved drugs.

The company has received no reports of illness associated with these products to date.

In addition to the voluntary recall of the above products, The One Minute Miracle Inc. has chosen to voluntarily withdraw the following products from the marketplace to provide its customers with the certainty of safety. Those products include all sizes and lots of Miracle Cholesterol, Miracle Night Time, Miracle Joint-Flex, Miracle Stud 72, Miracle Magic Man, Male Mint Gum, Miracle 48 Hrs, Miracle Magic Woman, Miracle Cougar, Miracle Cougar Gum, Miracle Cougar G-Spot, Miracle G-Spot, Vagina Rejuvenation, Miracle Anti-Wrinkle, Miracle Stud Delay, Miracle Male Stud Spray, Miracle Male Stud Coffee, Miracle Male Coffee, Male 10, Miracle Male Stud Sublingual, Male 72 Hr, Miracle Tongue Sublingual, Miracle Tongue and Master Blaster.

The One Minute Miracle is notifying its customers via U.S. Postal Service and is arranging for return of recalled products. Consumers that have Miracle Diet 30 and/or Miracle Rock 48 which are being recalled should stop using and return product(s) immediately to: The One Minute Miracle Inc. 3322 NE 166 Street, North Miami Beach, FL 33160

Consumers with questions regarding this recall can contact The One Minute Miracle Inc. by phone (305)947-6244 or email theoneminutemiracle@gmail.com Monday through Friday, 9:00am through 5:00pm EST. 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail of by fax. Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm disclaimer icon Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-0178.
(more…)

Contact:
Consumer:
1-800-984-0989

FOR IMMEDIATE RELEASE — August 26, 2015 — HORSHAM, PA — Bimbo Bakeries USA has initiated a voluntary regional recall of certain bread products under the Sara Lee®, Kroger®, Bimbo®, Nature’s Harvest®, Great Value and L’Oven Fresh® brands due to the possible presence of fragments of glass caused by a broken light bulb at one of its bakeries.

Recalled products are the fresh bread products listed below with Best By Date, UPC Code and Bakery Code 1658 that were bought in the states listed below. The Best By Date can be found on the lower front/top third of the bag, the Bakery Code is to the left of the Best By Date. The UPC Code can be found in the bottom right corner on the back/bottom of the bag.

The company announced the recall after receiving 3 consumer reports of small pieces of glass found on the outside of the bread. There are no reports of injury.

All recalled products are being removed from store shelves. No other products are affected.

Consumers who have purchased the product can return the product to its place of purchase for a full refund. Consumers with questions may contact the company at 1-800-984-0989 at any time 24 hours a day. (more…)

Recall Summary

Name of product: Huffy bicycles equipped with front disc brakes

Hazard:

An open quick release lever on the bicycle’s front wheel hub can come into contact with the front disc brake assembly, causing the front wheel to come to a sudden stop or separate from the bicycle, posing a risk of injury to the rider.

Consumer Contact: Huffy toll-free at 888-366-3828 from 8 a.m. to 8 p.m. ET Monday through Friday, email Service@Huffy.com or online at www.huffybikes.com and click on “Recalls” at the bottom of any page.

Report an Incident Involving this Product

Recall Details

Units

About 460

Description

The recalled products are all model year 2014 Huffy TR 745 and TR-S 740 bicycles with 27.5-inch wheels. “Huffy” is on the downtube of the frame of both bicycles and model name TR 745 or TR-S 740 is on the rear portion of the frame. The TR 745 has a green frame with model number 26504M on the bottom of the frame near the pedals. The TR-S 740 has a white frame and model number 26604M on the bottom of the frame near the pedals. Bicycles that have a green dot on the inside of the quick release lever are not included in this recall.

Incidents/Injuries

None reported (more…)

Class II Recall 114-2015
Health Risk: Low Aug 26, 2015

Congressional and Public Affairs
Alexandra Tarrant
(202) 720-9113

 

WASHINGTON, Aug. 26, 2015 – California Qi Li’s Braised Chicken, a Fremont, Calif., establishment, is recalling approximately 6,644 pounds of duck head and duck neck 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 soy sauce which is not declared on the product labels and has known allergens of soy and wheat.

The duck products were produced on various dates between Feb. 11, 2015 and Aug. 13, 2015. The following products are subject to recall: [View Labels (PDF Only)]

  • 10” x 8” vacuum sealed packages of “Chinese Brand Spicy Duck Heads”
  • 10” x 8” vacuum sealed packages of “Chinese Brand Spicy Duck Necks”

The products subject to recall bear establishment number “P-40286” inside the USDA Mark of Inspection. These items were shipped to retail locations in California.

The problem was discovered when an FSIS inspector reviewed product labels and noticed that soy sauce was not listed as an ingredient. Neither FSIS nor the company has received reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider. (more…)

Contact:
Consumer:
1-800-624-4123

Media:
Kirstie Foster
763-764-6364
Media.line@genmills.com

FOR IMMEDIATE RELEASE – August 26, 2015 – Minneapolis – General Mills today announced a voluntary Class I recall of a limited quantity of frozen Cascadian Farm Cut Green Beans produced over two days in March 2014. The recall is being issued as a precaution after one package of finished product tested positive for the presence of Listeria monocytogenes. No related illnesses have been reported in connection with this product.

This voluntary recall is limited to 10-ounce bags of frozen Cascadian Farm Cut Green Beans with either of two “Better If Used By” dates printed on the package:

10APR2016
11APR2016

The recalled product was produced and packaged in 2014. No other varieties or production dates of Cascadian Farm products are affected by this recall.

The Cascadian Farm frozen cut green beans were distributed to retail establishments nationwide.

Consumers are urged to dispose of the products affected by this recall. Consumers who have products covered by this recall may contact Cascadian Farm Consumer Relations at 1-800-624-4123 for a replacement. (more…)