Month: November 2017

For Immediate Release

November 30, 2017

Contact

Consumers

 spanishflycoteam@gmail.com
 941-800-2883

Announcement

Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.

Use of products with undeclared sildenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. To date, Nutra Labs Inc. has not received any reports of adverse events related to this recall. (more…)

Name of product:
RTV-X series utility vehicles
Hazard:

The seat belt stays can break, posing an injury hazard to consumers in the event of a crash.

Remedy:
Repair
Recall date:
November 30, 2017
Recall number:
18-704
Consumer Contact:

Kubota at 800-752-0290 from 8:30 a.m. to 4:30 p.m. PT Monday through Friday or online at www.kubota.com and click on More, then Safety and then Safety Notices for more information.

Recall Details

Description:

This recall involves Kubota RTV-X series utility vehicles with model numbers ending in 900, 1100, 1120D and 1140. The diesel-powered vehicles were sold in orange and camouflage. Kubota and Diesel are printed on the side of the rear bed box.  The model number is on the side of the unit and on the data plate located on the back of the cab, between the cab and the bed. The utility vehicles with the following serial numbers, located on the data plate, are included on this recall.

 

Model Serial Number Range Manufacture Date Range
RTV-X900 31229 through 42402 12/2015 through 6/2017
RTV-X1100 26899 through 35995
RTV-X1120D 18541 through 20746
RTV-X1140 10001 through 19546 6/2015 through 6/2017
Remedy:

Consumers should immediately stop using the recalled vehicles and contact an authorized Kubota dealer to schedule a free repair. The firm is contacting consumers directly.

Incidents/Injuries:

Kubota has received three reports of seat belt stays breaking worldwide. No incidents have been reported in the U.S. No injuries have been reported. (more…)

For Immediate Release

November 29, 2017

Contact

Consumers

 1-919-583-4366

Media

Frank Farrell
 1-919-583-4366

Announcement

Farrell Farms, Inc. of Goldsboro, NC is recalling 7 oz Dark Chocolate Almonds, 7 oz Dark Chocolate Cashews, and 7 oz Dark Chocolate Pecans, because these products may contain 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 these products.

The Dark Chocolate Almonds, Cashews, and Pecans were distributed in NC. Product was sold at fairs and festivals and via our website www.farrellfarms.com from October 16th, 2017 until November 17th, 2017.

The individual retail units are in a clear cellophane heat sealed package. The product is labeled as Farrell Farms with the address 200 Gin Road, Goldsboro, NC 27530 on the label. Format of labels on retail units are similar for almonds, cashews, and pecan products.

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

Name of product:
Bourbon Taster Glasses
Hazard:

The glasses can break during normal use, posing a laceration hazard.

Remedy:
Refund
Replace
Recall date:
November 29, 2017
Recall number:
18-046
Consumer Contact:

Libbey Glass at 800-982-7063 between 8 a.m. and 5 p.m. ET Monday through Friday or online at www.libbey.com and click on “Product Recall” for more information.

Recall Details

Description:

This recall involves 8 oz. Bourbon Taster Glasses.  The glasses are made of clear, colorless glass and measure about 3 7/8 inches tall.  The glasses have one of three logos laser-etched on the bottom of the glass: “Kentucky Bourbon Trail,” “Kentucky Bourbon Trail Craft Tours” or “SIV”.  The glasses were sold in boxed sets of four glasses and also sold individually.

Remedy:

Consumers should immediately stop using the recalled glasses and return them to the place of purchase for a full refund.  Commercial customers should contact Libbey to arrange for a credit, full refund or replacement.

Incidents/Injuries:

Libbey has received two reports of incidents involving 12 glasses breaking. No injuries have been reported. (more…)

Name of product:
Clay craft kits
Hazard:

Mold can be present in the clay, posing a risk of respiratory or other infections in individuals with compromised immune systems, damaged lungs or an allergy to mold.

Remedy:
Refund
Recall date:
November 29, 2017
Recall number:
18-045
Consumer Contact:

Toys“R”Us at 800-869-7787 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.toysrus.com and click on Product Recalls for more information.

Recall Details

Description:

This recall involves “totally me!” clay craft kits. Model number AD11244 is printed on the bottom of the box. The “totally me!” logo is printed on the front of the craft kit box.

The clay craft kits contain:

  • two bricks of air dry acrylic paints
  • paint brush
  • three sculpting tools
  • plastic rolling pin
  • sponge
  • 19.5” x 15.25” instructional work mat
  • two texture rollers
  • plastic clay cutting tool
  • 12” ribbon
Remedy:

Consumers should immediately stop using the recalled craft kits and return them to Babies“R”Us or Toys“R”Us for a full refund or store credit.

Incidents/Injuries:

The firm has received three reports of mold in the clay. No injuries have been reported. (more…)

For Immediate Release

November 24, 2017

Contact

Consumers

 drug.safetyUSA@sunpharma.com
 1-800-406-7984

Media

Gaurav Chugh
 gaurav.chugh@sunpharma.com
 91 22 4324 4324, Xtn 5373

Announcement

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

Use of Riomet® (Metformin Hydrochloride Oral Solution) potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. To date, SPII has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

November 23, 2017

Contact

Consumers

 1-800-463-6144

Announcement

Leclerc Foods has initiated a limited voluntary recall of a single lot of Fit & Active Chocolatey Chip Protein Meal Bars packages with UPC Code 41498-18695 and only affected products with a “best by” date of May 24, 2018.

The recall was initiated as a precautionary measure after a small piece of yellow plastic was discovered by a consumer. No illness or injury has been reported. (more…)

For Immediate Release

November 22, 2017

Contact

Consumers

Burgess D. Goodman
 303-733-7311

Announcement

Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, because they may contain 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 these products.

The Trail Mixes were distributed from June 1, 2017 through November 7, 2017 with a sell by date range from December 1, 2017 through May 7, 2018 to AR, AZ, CA, CO, IA, IL, KS, MO, MT, NE, NM, OK, TX, UT, WA, WY, to car washes, hospitals, colleges, retail stores, national parks, and liquor stores via UPS, FedEx or direct deliveries.

The product can be identified as an 8oz. bag with either Colorado Nut Company label on the front of the bag or a private label with “Distributed by Colorado Nut Company” on the bottom right hand corner of the back label. The item name and numbers are: Cashew Cranberry Cherry Jubilee UPC 018142352161, Oat Bran Nutty Crunch UPC 018142352130, Honey Nutty Granola UPC 018142352147, Peanut Delight UPC 018142352512, and Frontier Trail Mix UPC 018142352987 (Frontier Trail Mix is sold on Frontier Airlines).

No illnesses have been reported to date in connection with this problem. (more…)

Name of product:
Street Charge solar powered mobile device charging stations
Hazard:

The weld connecting the top and bottom posts can fail and allow the top post to fall, posing an impact hazard to nearby consumers.

Remedy:
Repair
Recall date:
November 22, 2017
Recall number:
18-703
Consumer Contact:

Goal Zero toll-free at 877-897-3193 from 8 a.m. to 5 p.m. MT Monday through Friday, or online at www.goalzero.com and click on “Product Notifications” for more information.

Recall Details

Description:

This recall involves Street Charge solar powered charging stations used to charge up to six mobile devices at a time. The charging stations are approximately 150 inches tall by 63 inches wide by 54 inches deep. Aluminum panels cover three sides of the tree-shaped charging station’s top post. “Street Charge” is etched on the product panels.

Remedy:

Consumers should immediately stop using the recalled charging stations until a free inspection and repair of weld connections is conducted by Goal Zero. The firm is notifying all known customers.

Incidents/Injuries:

The firm has received three reports of the top post detaching. No injuries have been reported. (more…)

Name of product:
Allura decking
Hazard:

The recalled decking can deteriorate and crack, causing the deck surfacing to break. Consumers can fall through broken decking and suffer serious injuries.

Remedy:
Repair
Recall date:
November 21, 2017
Recall number:
18-044
Consumer Contact:

Plycem toll-free at 844-452-6787 from 8 a.m. to 5 p.m. CT Monday through Friday or online at www.allurausa.com and click on Decking Recalls to complete an online registration form and for more information.

Recall Details

Description:

The recall involves Allura™ fiber cement decking and fascia. The recalled decking was sold in 12-foot lengths and is 6 inches wide and one inch thick, and came in two styles: a hidden fastener application and a direct screw application. The recalled Allura™ fiber cement fascia, which was for vertical applications only, was sold in 12-foot lengths, is 8- and 12-inches wide and 7/16 inches thick. The decking and fascia were sold in a natural wood color with a wood grain texture. There are no labels or other identifying marks on the decking materials.

Remedy:

Consumers should immediately stop using decks with the recalled decking materials and contact Plycem to schedule a free repair. Plycem is contacting all known purchasers directly.

Incidents/Injuries:

Plycem has received three reports of the recalled decking cracking, resulting in one report of a leg injury to an adult male whose leg went through the cracked decking. (more…)