World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads Contamination

For Immediate Release

August 13, 2018

Contact

Consumers

World Organix LLC
  fdarecall@blissfulremedies.com
 1-800-435-8533

Announcement

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls. (more…)

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

For Immediate Release

August 9, 2018

Contact

Consumers

Jonathan H. Olive
  recalls@wprx.com
 888-354-9939

Announcement

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product. (more…)

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

For Immediate Release

August 8, 2018

Contact

Consumers

Joan Sanger, Site Head of Quality
 386-239-8787

Announcement

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. THolly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

Risk Statement: Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or  immuno-compromised. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall. (more…)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

For Immediate Release

August 8, 2018

Contact

Consumers

Qualanex Customer Service – Recalls
  recall@qualanex.com
 1-800-505-9291

Announcement

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level.  This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer), as per International Agency for Research on Cancer (IARC) classification.  To date, Camber has not received any reports of adverse events related to this recall.

Valsartan Tablets, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles & 90ct bottles, all associated codes are provided in the table below with lot # and expiration dates.

Product Description NDC Number Batches Exp. Date
Valsartan Tablets USP, 40mg 31722-745-30 All lots 07/2018 – 06/2020
Valsartan Tablets USP, 80mg 31722-746-90 All lots 07/2018 – 06/2020
Valsartan Tablets USP, 160mg 31722-747-90 All lots 07/2018 – 06/2020
Valsartan Tablets USP, 320mg 31722-748-90 All lots 07/2018 – 06/2020

Valsartan Tablets were distributed Nationwide to Wholesalers, Distributors, Hospitals and Retail Pharmacies and Mail Order Pharmacies.

Qualanex, LLC will be notifying Camber’s distributors and other customers by recall letter and arranging for return of all recalled products.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this product. Pharmacies and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall can contact Qualanex, LLC by phone at 1-800-505-9291 or email recall@qualanex.com from Monday to Friday between 9am – 5pm Central Time.  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. (more…)

“Country Favor Inc Issues Alert on Undeclared Sulfites in “Best Taste Brand Snack Ginger Sliced”

For Immediate Release

August 6, 2018

Contact

Consumers

 718-418-9400

Announcement

Country Favor Inc. of Maspeth, New York is recalling its 7 ounce packages of “Best Taste Brand Snack Ginger Sliced” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

The recalled “Best Taste Brand Snack Ginger Sliced” were distributed nationwide in retail stores. The product comes in a 7 ounce, un-coded flexible plastic package.

No illnesses or allergic reactions involving this product have been reported to date. (more…)

Harbor Freight Tools Recalls Handgun Safes Due to Serious Injury Hazard

Name of product:
Electronic handgun safes
Hazard:

The handgun safes can open without the use of a key or combination upon impact and allow unintended access to the contents of the safe, posing a risk of serious injury to children and others.

Remedy:
Refund
Recall date:
August 9, 2018
Units:
About 25,000
Consumer Contact:

Harbor Freight Tools at 800-444-3353 Monday through Friday from 8 a.m. to 4:30 p.m. PT, email at recall@harborfreight.com or online at www.harborfreight.com and click on “Recall Safety Information” on the bottom of the homepage for more information.

Recall Details

Description:

This recall involves two models of 0.17 cubic foot capacity electronic handgun safes sold under two different brand names, Union Safe Company and Bunker Hill Security. The recalled safes are dark gray and the SKU number is printed on a permanent label on the door. The brand is printed on the permanent label on the door and molded into the combination touch-pad panel.

Brand

SKU

Union Safe Company

62984

Bunker Hill Security

61581

Remedy:

Consumers should immediately stop using the recalled handgun safes, secure the handguns to keep them away from children and return the safes to any Harbor Freight Tools location for a full refund of the purchase price in the form of a Harbor Freight Tools gift card.

Incidents/Injuries:

None Reported (more…)

Vitamix Recalls Ascent and Venturist Series Blending Containers Due to Laceration Hazard

Name of product:
Ascent™ and Venturist™ Series 8-ounce and 20-ounce blending containers
Hazard:

The containers can separate from the blade’s base exposing the blades, posing a laceration hazard to consumers.

Remedy:
Repair
Recall date:
August 9, 2018
Units:
About 105,000 (In addition, about 5,300 were sold in Canada)
Consumer Contact:

Vitamix toll-free at 888-847-8842 from 7 a.m. to 6 p.m. CT Monday through Friday or online at http://www.vitamix.com and click on Customer Service and Voluntary Recalls or www.recallrtr.com/blender for more information.

Recall Details

In Conjunction With:
Description:

This recall involves Ascent™ and Venturist™ series 8-ounce and 20-ounce blending containers with blade date codes March 2018 (“03-18”) or earlier. Date codes are in the format MM-YY; for example, March 2018 is “03-18.” If the blade base is marked on the bottom with a green or orange dot, the container has already been repaired. The Vitamix logo is printed on the blending container. The blade date code is laser-etched onto the top of the blade in the blade base. The products have a clear container and a black blade base and were sold separately and with Vitamix Venturist™ Model 1200 blenders.

Remedy:

Consumers should immediately stop using the recalled blending containers and contact Vitamix for a free repair kit. Vitamix is sending repair kits to consumers it can identify.

Incidents/Injuries:

Vitamix has received 11 reports of lacerations when consumers’ hands came in contact with exposed blades. (more…)

Bobcat Company Recalls Utility Vehicles Due To Burn and Fire Hazards (Recall Alert)

Name of product:
Bobcat 3400 and 3400XL utility vehicles
Hazard:

The utility vehicle’s exhaust header pipe can crack, posing burn and fire hazards.

Remedy:
Repair
Recall date:
August 8, 2018
Units:
About 2,700
Consumer Contact:

Bobcat online at www.bobcat.com and click on the Find a Dealer link at the top of the page, or at 800-743-4340 from 7:30 a.m. to 4:30 p.m. CT Monday through Friday for more information.

Recall Details

Description:

This recall involves model year 2015 through 2018 Bobcat 3400 and 3400XL gas engine-equipped utility vehicles manufactured by Polaris Industries. The recalled utility vehicles are white and black with orange decals and have one or two rows of seats and a rear box. “Bobcat” is printed on the hood of the utility vehicle and “3400” or “3400XL” is printed on the rear box. The model and vehicle identification number (VIN #) can be found on a label under the seat and storage bin on the passenger side. The following models and VIN ranges are being recalled:

Year

Model

VIN Range

2015

3400 4X GAS

B3FL11001 through B3FL11911

3400 4X GAS DLX

B3FN11001 through B3FN11286

2016

3400 4X GAS

B3FL12001 through B3FL12803

3400 4X GAS DLX

B3FN12001 through B3FN12245

2017

3400 4X GAS

B3FL17001 through B3FL17580

3400 XL GAS

B3FN17001 through B3FN17124

2018

3400 4X GAS

B3FL18001 through B3FL18097

3400 XL GAS

B3FN18001 through B3FN18065

Remedy:

Consumers should contact an authorized Bobcat dealer to schedule a free repair. Bobcat is contacting all known purchasers directly.

Incidents/Injuries:

Bobcat has received seven reports of cracked exhaust pipes. No injuries or fires have been reported. (more…)

Polaris Recalls Gravely Utility Vehicles Due To Fire and Burn Hazards (Recall Alert)

Name of product:
Gravely Atlas JSV 3000 and 6000 utility vehicles
Hazard:

The utility vehicle’s exhaust header pipe can crack, posing fire and burn hazards.

Remedy:
Repair
Recall date:
August 8, 2018
Units:
About 2,100
Consumer Contact:

Gravely at 877-740-7060 from 8 a.m. to 4:30 p.m. ET Monday through Friday or online at www.gravely.com and click on the Product Support link at the bottom of the page, then select Product Safety Recall in the menu on the left of the page for more information.

Recall Details

Description:

This recall involves all model year 2015 through 2018 Gravely Atlas JSV 3000 and 6000 gas-engine-powered utility vehicles. The recalled utility vehicles were sold in red and have one or two rows of seats and a rear box. “Gravely” is printed on the rear box, and “Atlas” is printed on the hood of the utility vehicle. The model and serial number can be found on the driver’s side and are visible from the front wheel well. The fol lowing model numbers and serial number ranges are being recalled:

Year

Model

Serial Number Range

2015

996200 Base

150100, 150102 – 150299, 150310, 150321, 150332, 150343, 150354, 150365, 150376, 150387, 150398, 150409 – 150771, 150774 – 150803 and

150805 – 151173

996201 Crew

150100 – 150299, 150310, 150321, 150332, 150343, 150354, 150365, 150376, 150387, 150398, 150409 – 150599 and 150601 – 150641

2016

996200 Base

160100 – 160299, 160310, 160321, 160332, 160343, 160354, 160365, 160376, 160387, 160398 and 160409 – 160640

996201 Crew

160100 and 160102 – 160112

2017

996200 Base

170100 – 170256

996201 Crew

170100 – 170102 and 170108 – 170152

2018

996200 Base

180101, 180105 – 180116, 180118 – 180136, 180138 – 180149, 180151 – 180154, 180158 – 180161, 180163 – 180166, 180168 – 180170, 180172,

180174 – 180178, 180181 – 180182, 180186 – 180187, 180190, 180192, 180199, 180202, 180205 – 180206, 180209 – 180211, 180214 – 180215, 180218 and 180220 – 180222

Remedy:

Consumers should contact an authorized Gravely dealer for a free repair. If the exhaust system becomes noisier, consumers should immediately stop using the recalled utility vehicles. Gravely is contacting all known purchasers directly.

Incidents/Injuries:

Gravely has received seven reports of cracked header exhaust pipes. No injuries have been reported. (more…)

NEMO Equipment Recalls Stargaze Recliner Chairs Due to Fall Hazard

Name of product:
Stargaze recliner chairs
Hazard:

The plastic joint supports attached to the legs of the chairs can break, posing a fall hazard.

Remedy:
Replace
Recall date:
August 7, 2018
Units:
About 7,500 (About 15,500 units were previously recalled in February 2018)
Consumer Contact:

NEMO Equipment at 800-997-9301 from 9 a.m. to 5 p.m. ET Monday through Friday, email at journey@nemoequipment.com or online at www.nemoequipment.com and click on Product Recalls for more information or www.nemoequipment.com/product-recalls/stargaze-recliner-hubs/.

Recall Details

Description:

This recall involves the Stargaze Recliner, Stargaze Recliner Low, and Stargaze Recliner Luxury lifestyle camping chairs. These portable swinging and reclining outdoor chairs have an aluminum frame and black and gray monofilament mesh seat, and weigh between five and seven pounds. They were sold in four colors: birch leaf green, graphite, verdigris (teal) and Sedona (red). They come in a black, padded carrying case, and are used as a portable seat for camping and outdoor activities. The model name is printed on the pocket on the inside right side of the seat. The NEMO name and logo is attached to the back of the seat as a stitched logo. The three manufacturing lots included in this recall are marked with November 2017, December 2017, March 2018 or May 2018 date codes. The date code can be found on the plastic hub located on the inside edge of the leg strut. The date code is in a clock format: The numbers around the circle correspond to the 12 months of the year, the arrow points to the month of manufacture and the numbers on either side of the arrow represent the last two digits of the year.

Remedy:

 Consumers should immediately stop using the recalled chairs and contact NEMO Equipment for a free inspection and, if necessary, a free replacement chair.

Incidents/Injuries:

The firm has received 14 reports of the joint supports breaking. No injuries have been reported. (more…)