Month: September 2018

For Immediate Release

September 5, 2018

Contact

Consumers

Stericycle Customer Service – Recalls
 Camber7719@stericycle.com
 1-888-548-8526
Med Line
 1-866-495-1995

 

Announcement

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg.

A consumer who inadvertently consumes Losartan may experience renal dysfunction, hyperkalemia, and hypotension. Hypotension (dizziness, fatigue) would be the most likely risk if Losartan was taken by an otherwise healthy patient (no concomitant conditions other than asthma or allergic rhinitis; no other concomitant medications). Losartan has a warning for fetal toxicity. There is risk of fetal morbidity and death if pregnant women unknowingly take Losartan instead of Montelukast. Camber Pharmaceuticals, Inc has not received any reports of adverse events related to this recall. (more…)

For Immediate Release

September 6, 2018

Contact

Consumers

 877-550-5059

Media

Matt White, Pharm. D.
 877-550-5059

Announcement

SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

Administration of a drug product that may contain precipitate has the potential to result in serious adverse events due to dosages that may be lower than intended and could lead to therapeutic failures. Intravenous administration of a product with the precipitate can result in blockage of blood vessels and/or catheter occlusions which could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to permanent lung damage.

SCA Pharmaceuticals has received one (1) customer complaint reporting the presence of precipitate. To date, no adverse events have been reported. Conservatively, the firm is voluntarily recalling seven (7) lots of the same product that are within their Beyond Use Date. These lots are listed in the table below: (more…)

Class II Recall 077-2018
Health Risk: Low Sep 5, 2018

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

 

WASHINGTON, Sept. 5, 2018 – New York Style Sausage Co., a Sunnyvale, Calif. establishment, is recalling approximately 371 pounds of raw chorizo sausage products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains sesame seed, which is not declared on the product label.

The raw, Salvadoran chorizo sausage items were produced on June 8, 2018. The following products are subject to recall: [View Labels (PDF only)]

  • 8-oz. cardboard packages containing “Artesana Specialty Sausages CHORIZO SALVADORAN RECIPE ALL NATURAL.” The product is labeled “Keep refrigerated or frozen” and does not bear a use by or sell by date.

The products subject to recall bear establishment number “EST. 9027” inside the USDA mark of inspection. These items were sold at farmers markets in California.

The problem was discovered by FSIS during routine inspection label verification activities.

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…)

Class I Recall 076-2018
Health Risk: High Sep 5, 2018

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

 

WASHINGTON, Sept. 5, 2018 – Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may be contaminated with extraneous materials, specifically metal pieces, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat, fully cooked chicken products were produced on various dates from July 4 through July 17, 2018. The following products that are subject to recall can be found here. [View Labels (PDF only)]

The products subject to recall bear establishment number “P-20214” inside the USDA mark of inspection. These items were shipped to distributors, restaurants and further processing locations nationwide.

The problem was discovered after the firm received a customer complaint on July 27, 2018. The firm investigated to determine the nature of the foreign material complaint and notified FSIS of the findings on Sept. 4, 2018.

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

(more…)

Class I Recall 075-2018
Health Risk: High Sep 5, 2018

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

 

WASHINGTON, Sept. 5, 2018 – Caito Foods, LLC., an Indianapolis, Ind. establishment, is recalling approximately 242 pounds of fully cooked chicken salad product 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 tree nuts (walnut), a known allergen, which is not declared on the product label.

The ready-to-eat, fully cooked, not shelf stable chicken salad products were produced on August 31, 2018. The following products are subject to recall:  [View Label (PDF only)]

  • 15-oz. plastic clamshell packages containing “Derby City Chicken Salad WITHOUT Walnuts” with lot code “GHMW 243 03” and “Sell By: 09/04/18” on the label.

The products subject to recall bear establishment number “P-39985” inside the USDA mark of inspection. These items were shipped to retail locations in Illinois, Indiana, Kentucky and Ohio.

The problem was discovered after the firm received a consumer complaint.

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

September 5, 2018

Contact

Consumers

Beaumont Bio Med
 recall@naturalief.com
 800-332-2249

Announcement

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

Risk Statement: The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. To date, Beaumont Bio Med has not received any reports of adverse events related to this recall. (more…)

Name of product:
Links Series chargers models 28080, 28090 and 28100
Hazard:

The control board can fail and overheat, posing fire and burn hazards.

Remedy:
Repair
Recall date:
September 6, 2018
Units:
About 19,000
Consumer Contact:

Lester Electrical at 800-295-2086 from 7:30 a.m. to 4:30 p.m. CT Monday through Friday, email at service@lesterelectrical.com or online at www.lesterelectrical.com and click on “Service & Support” and then “Links Series Field Action” for more information.

Recall Details

Description:

This recall involves Links Series chargers with model numbers 28080, 28090 or 28100. The chargers are used with golf carts. The recalled chargers are black or aluminum and measure approximately 11 inches long by 8 ¾ inches wide by 9 ½ inches tall. “Lester Electrical” and “Links Series” are printed on the front of the recalled chargers along with a picture of a golfer. The recalled chargers were manufactured between week 29 of 2014 and week 48 of 2016. The date code is embedded in the serial number as the first four digits with the first and second digits representing the week and the third and fourth digits representing the year. The serial and model numbers are printed on the ratings label on the back of the charger.

Model Numbers

Serial Number Range

28080

2914XXXXX through 4816XXXXX

28090

28100

Remedy:

Consumers should immediately stop using the recalled chargers and contact Lester Electrical to receive a free replacement control board or schedule a free repair.

Incidents/Injuries:

The firm has received 12 reports of failed control boards that showed signs of overheating or burning. No injuries have been reported. (more…)

Name of product:
Swivel barstools
Hazard:

The wood joints on the barstool can break; posing a fall hazard.

Remedy:
Refund
Recall date:
September 6, 2018
Units:
About 1,100 (in addition, about 500 were sold in Canada)
Consumer Contact:

HomeGoods at 800-888-0776 from 9 a.m. to 6 p.m. ET Monday through Friday or online at www.homegoods.com and click on Customer Service at the bottom of the page.

Marshalls toll-free at 888-627-7425 from 9 a.m. to 6 p.m. ET Monday through Friday or online at www.marshallsonline.com and click on Customer Service at the bottom of the page.

T.J. Maxx at 800-926-6299 from 9 a.m. to 6 p.m. ET Monday through Friday or online at  www.tjmaxx.com  then click on Contact Us at the bottom of the page.

Recall Details

In Conjunction With:
Description:

This recall involves TJX swivel barstools with a beige, blue or gray fabric back and seat, and wooden legs. The barstools measure about18 inches wide, 22.8 inches deep and 40.9 inches high. One of the following tag numbers is printed on the product hang tag: 081578, 081582, 081586, 081640, 081643, 081651, 081656, 081658, 081660, 527110, 527113 , 527118, 527121, 527126, 527128, 533088, 726376, 726377, 726380, 726386, 726387 and 726393.

Remedy:

Consumers should immediately stop using the recalled barstools and return them to any Home Goods, Marshalls or T.J. Maxx store for a full refund.

Incidents/Injuries:

The firm has received four reports of the barstool breaking, including three reports of minor injuries. (more…)

Name of product:
Model year 2018 Polaris Ranger 500, Ranger 570, Ranger EV, and Ranger EV LI-ION recreational off-highway vehicles (ROVs)
Hazard:

The front lower control arms can separate, posing a crash hazard.

Remedy:
Repair
Recall date:
September 5, 2018
Units:
About 1,000
Consumer Contact:

Polaris at 800-765-2747 from 7 a.m. to 7 p.m. CT Monday through Friday or online at www.polaris.com and click on “Off Road Safety Recalls” for more information. In addition, check your vehicle identification number (VIN) on the “ Product Safety Recalls ” page to see if your vehicle is included in any recalls.

Recall Details

Description:

The recall involves model year 2018 Polaris Ranger 500, Ranger 570, Ranger EV and Ranger EV LI-ION recreational off-highway vehicles. The Ranger 500 vehicles were sold in red and green. They have “POLARIS” stamped on the front grille, “500” decals on the front fenders, and “Ranger” decals on the rear fenders. The Ranger 570 vehicles were sold in two- and four-seat models in green, blue, and camo. They have “POLARIS” stamped on the front grille, “570” decals on the front fenders, and “Ranger” decals on the rear fenders. The Ranger EV vehicles were sold in gray and camo. They have “POLARIS” stamped on the front grille and “Ranger” decals on the rear fenders. The Ranger EV LI-ION vehicles were sold in camo. They have “POLARIS” stamped on the front grille and “Ranger” decals on the rear fenders.

The Vehicle Identification Number (VIN) and model number may be found on a label inside the left rear wheel well.

Model Number

Model/Color

R18RMA50B1

RANGER 500 – INMOLD SAGE GREEN

R18RMA50B4

RANGER 500 – INMOLD SOLAR RED

R18RMA57B1

RANGER 570 – INMOLD SAGE GREEN

R18RMA57B9

RANGER 570 – POLARIS PURSUIT CAMO

R18RMAE4G8

RANGER EV – INMOLD AVALANCHE GRAY

R18RMAE4G9

RANGER EV – POLARIS PURSUIT CAMO

R18RMAL4G9

RANGER EV LI-ION – POLARIS PURSUIT CAMO

R18RME57BV

RANGER 570 EPS – PAINT NAVY BLUE METALLIC

R18RNA57B1

RANGER CREW 570-4 – INMOLD SAGE GREEN

R18RNA57B9

RANGER CREW 570-4 POLARIS PUR CAM

R18RNE57BV

RANGER CREW 570-4 EPS – NAVY BLUE MET

Remedy:

Consumer should immediately stop using the recalled ROVs and contact a Polaris dealer to schedule a free repair. Polaris is contacting all registered owners directly.

Incidents/Injuries:

Polaris has received six reports of lower control arms separating. No injuries have been reported. (more…)

Name of product:
Ideal-Air 175-pint industrial grade humidifiers
Hazard:

The humidifiers can overheat while in use, posing fire and shock hazards.

Remedy:
Refund
Recall date:
September 5, 2018
Units:
About 400 (In addition, 70 were sold in Canada)
Consumer Contact:

Sunlight Supply toll-free at 888-582-2762 from 9 a.m. to 5 p.m. ET Monday through Friday, e-mail at RMA@sunlightsupply.com or online at www.sunlightsupply.com and click on “Voluntary Recall” for more information.

 ​​​​​

Recall Details

In Conjunction With:
Description:

This recall involves Ideal-Air 175-pint industrial grade humidifiers. The recalled humidifiers are black and have the “Ideal-Air” logo printed near the bottom.

Remedy:

Consumers should immediately stop using the recalled humidifiers and return them to the place of purchase for a full refund of the purchase price in the form of store credit.

Incidents/Injuries:

The firm is aware of 5 incidents of the humidifier overheating. No injuries have been reported. (more…)