Author: Marianne Halterman

  • Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging

    Summary

    Company Announcement Date: May 18, 2023
    FDA Publish Date: May 19, 2023
    Product Type: Drugs, Over-the-Counter Drugs
    Reason for Announcement: Device & Drug Safety/Mislabeling
    Company Name: NOVIS PR LLC
    Brand Name: G-SUPRESS DX
    Product Description: Cough Suppressant, expectorant, nasal decongestant pediatric drops

    Company Announcement

     05/15/23– San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR LLC.

    Anesthetic/Analgesic product contains 60% ethyl alcohol and 5% benzocaine. There is a probability of serious adverse events with a product containing alcohol including alcohol toxicity. Infants and young children are prone to profound hypoglycemia coma, and hypothermia from ingesting relatively small amounts of ethanol, and deaths have been reported. Furthermore, the product contains benzocaine but does not include a Warning for methemoglobinemia which is a condition in which too little oxygen is delivered to your cells that can be life-threatening. To date, Novis PR LLC has not receive d any reports of adverse events or injuries related to this recall.

    G-Supress DX Pediatric Drops is a cough suppressant, expectorant and nasal decongestant used for the temporarily relief of the common cold symptoms, supplied in 1 oz. bottles packaged in a carton box. Oral anesthetic/analgesic liquid used for temporary relief for the mouth and gums supplied in 0.5 fl. oz. (15 mL) bottles. Lot D20911 was distributed among pharmacies in Puerto Rico.

    Novis PR LLC is notifying its distributors and customers by email and telephone calls and arranging return of recalled lot.  Consumers/distributors/retailers that have affected lot should stop using and return to place of purchase.

    Consumers with questions regarding this recall can contact Novis PR LLC at 787-767-2072 Monday through Friday from 8:00AM – 4:00 pm 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 or by fax.

    • Complete and submit the report Online
    • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

    Spanish Version


    Company Contact Information

    Consumers: Novis PR LLC – 787-767-2072

    Product Photos

    G-SUPRESS DX Product label
    G-SUPRESS DX Product label
  • How to Protect Your Family from CO Poisoning and Other Post-Storm Dangers this Hurricane Season

    WASHINGTON, D.C. – June 1 marks the start of the 2023 Atlantic hurricane season. The U.S. Consumer Product Safety Commission (CPSC) is warning consumers about the increased risk of carbon monoxide (CO) poisoning, fires and electric shock after hurricanes and severe storms hit.

    “Hurricanes and major storms in the U.S. have increased in frequency and severity in recent years. This hurricane season may bring widespread destruction that could impact millions of Americans,” said CPSC Chair Alex Hoehn-Saric. “I urge consumers to follow CPSC’s safety tips to prepare ahead of storms to prevent loss of life in a storm’s aftermath.”

    Consumers need to be especially careful when storms knock out electrical power. CO poisoning from gasoline-powered portable generators can kill in minutes. CO is called the invisible killer because it is colorless and odorless. CO poisoning from portable generators can happen so quickly that exposed persons may become unconscious before recognizing the symptoms of nausea, dizziness or weakness.

    An average of nearly 100 consumers die in the U.S. each year from CO poisoning from portable generators, according to CPSC’s latest report on Non-Fire Carbon Monoxide Deaths Associated with the Use of Consumer Products (54-page PDF).

    CPSC data show African Americans are at higher risk of death 

    An earlier CPSC report (38-page PDF) shows that from 2011 through 2021, where race was known, non-Hispanic Black or African Americans accounted for 23 percent of generator-related CO deaths, which is much higher than their share in the U.S. population.

    Consumers should follow these safety tips to protect their families during hurricane season. The Atlantic hurricane season typically lasts from the beginning of June to the end of November.

    Loss of Power—Using a Generator Safely

    • NEVER operate a portable generator inside a home, garage, basement, crawlspace or shed. Opening doors or windows does not provide enough ventilation to prevent the buildup of lethal levels of CO.
    • Operate portable generators outside only, at least 20 feet away from the house, and direct the generator’s exhaust away from the home and any other buildings that someone could enter, while keeping windows and other openings closed in the path of the generator’s exhaust. Do not operate a generator on an outside porch or in a carport. They are too close to the home. 
    • Follow portable generator instructions about electrical shock hazards in inclement weather, which may include use of an NFPA-rated non-combustible generator tent or may state to wait until rain passes.
    • Check that portable generators have been maintained properly, and read and follow the labels, instructions, and warnings on the generator and in the owner’s manual.
    • Look for portable generators that have a CO shut-off safety feature, which is designed to shut the generator off automatically when high levels of CO are present around the generator. These models may be advertised as certified to the latest safety standards for portable generators–PGMA G300-2018 and UL 2201–which are estimated to reduce deaths from CO poisoning by 87% and 100%, respectively. UL 2201 certified models have reduced CO emissions in addition to the CO shut-off feature.

    Check CO and Smoke Alarms

    • Working smoke and CO alarms save lives! Install battery-operated CO alarms or CO alarms with battery backup on each level and outside separate sleeping areas at home. Interconnected CO alarms are best; when one sounds, they all sound. 
    • Make sure smoke alarms are installed on every level and inside each bedroom at home.
    • Test CO and smoke alarms monthly to make sure they are working properly and replace batteries, if needed. Never ignore an alarm when it sounds. Get outside immediately. Then call 911.

    Dangers with Charcoal and Candles

    • Never use charcoal indoors. Burning charcoal in an enclosed space can produce lethal levels of carbon monoxide. Do not cook on a charcoal grill in a garage, even with the garage door open.
    • Use caution when burning candles. Use flashlights or battery-operated candles instead. If using candles, do not burn them on or near anything that can catch fire. Never leave burning candles unattended. Extinguish candles when leaving the room and before sleeping.

    Dangers with Wet Appliances:

    • Look for signs that your appliances have gotten wet. Do not touch wet appliances that are still plugged into an electrical source.
    • Before using your appliances, have a professional or your gas or electric company evaluate them for safety. Replace all gas control valves, electrical wiring, circuit breakers and fuses that have been under water.

    Dangers with Gas Leaks: 

    • If you smell or hear gas leaking, leave your home immediately and contact local gas authorities from outside the home. Do not operate any electronics, such as lights or phone, before leaving.

    CPSC resources:

    PSA – Hurricane Safety Tips (English)

    PSA – Hurricane Safety Tips (Spanish)

    Carbon Monoxide Safety Center

  • Head Towards Safety, Wear a Helmet

    Hi Neighbor!

    May is National Bicycle Safety Month and May 19th is Bike to Work Day. Whether you ride to work or school, hit the trails, or cycle with the whole family, remember to always wear a bike helmet to reduce the risk of injury.    

    Helmets are also essential gear for other sports, including scootering and skateboarding. 

    Did you Know? There were more than 405,000 estimated bicycle-related injuries (non-powered bikes) treated in hospital emergency departments for all ages last year; and more than 79,000 of those were head injuries.  

    Learn more about helmet safety in our “print and share” infographic below.

    Helmet Safety Infographic

  • Diamond Visions Recalls Plush Monkey Toys Due to Choking Hazard

    Recall Date: April 27, 2023

    Recall number: 23-194

    Recall Summary

    Name of Product: Screaming Plush Monkey Toys

    Hazard: The eyes on the toy can detach, posing a small part choking hazard to children.

    Remedy: Refund

    Consumer Contact: Diamond Visions at 866-600-0722 from 8 a.m. to 4 p.m. CT Monday through Friday, email at jheinzel@diamond-visions.com, or online at https://diamond-visions.com/recall-notice/ or www.diamond-visions.com and click on “recall” for more information.

    Pictures available here:

    Recall Details

    Units: About 6,000

    Description: This recall involves Screaming Plush Monkeys in brown, blue and pink. The monkeys are 23 inches long and make a scream-like sound when the front paw is pressed. The front paws of the plush monkey have Velcro so that the monkey’s arms can be wrapped around a consumer’s neck. Model TM-3280 and Diamond Visions, Inc. are printed on a tag on the monkey.

    Remedy: Consumers should immediately take the recalled toys away from children and contact Diamond Visions for instructions on how to receive a full refund.

    Incidents/Injuries: None reported

    Sold At: Independent hardware and variety stores nationwide from September 2021 through November 2022 for about $6.

    Importer(s): Diamond Visions Inc., of Oak Creek, Wisconsin

    Manufactured In: China

    Note: Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

  • EGL Motor Recalls ACE-branded Youth All-Terrain Vehicles (ATVs) Due to Violation of Federal ATV Safety Standard; Risk of Serious Injury or Death

    Recall Date: April 27, 2023

    Recall number: 23-191

    Recall Summary

    Name of Product: EGL Motor ACE-branded Youth All-Terrain Vehicles (ATVs)

    Hazard: The recalled ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. The Ace-branded K125 and C125 models exceed the maximum speed limitations for vehicles intended for children aged 10 and older, posing a risk of high-speed crash. For T125 and C125 models, the parking brakes do not prevent movement of the vehicle, posing a collision hazard to consumers if the vehicle is parked on an incline. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.

    Remedy: Repair

    Consumer Contact: EGL Motor toll-free at 866-496-9919 from 9 a.m. to 5 p.m. CT, Monday through Friday, by email at service@eglmotor.us or online at https://www.eglmotor.us/recall.html or www.eglmotor.us and click on “RECALL” at the top of the page for more information.

    Pictures available here: https://www.cpsc.gov/Recalls/2023/EGL-Motor-Recalls-ACE-branded-Youth-All-Terrain-Vehicles-ATVs-Due-to-Violation-of-Federal-ATV-Safety-Standard-Risk-of-Serious-Injury-or-Death

    Recall Details

    Units: About 4,000

    Description: The recall involves EGL Motor’s ACE-branded Youth ATVs, models K125, T125 and C125. The vehicles were sold in various colors including orange, red, blue, pink and green and marketed for children ages 10 and older. The model name “ACE POWER K125,” “ACE POWER T125” or “ACE POWER CONQUEROR” is displayed on both sides of the vehicle. The model number is stamped into the metal plate located on the left side, under the rear body. The phrase “This ATV is subject to EGL MOTOR INC’s action plan approved by U.S. Consumer Product Safety Commission” is printed on a label located under the model number plate.

    Remedy: Consumers should immediately stop using the recalled ATVs and contact EGL Motor to schedule an appointment for a free repair from an authorized repair shop. The firm will repair reflectors, headlights, chest protector, engine stop switch, parking brake, maximum speeds, and spark arrestor on the recalled models.

    Incidents/Injuries: None reported

    Sold At: AWL Distribution, BV Powersports, and other authorized dealerships nationwide and online at www.Dmwholesalepowersports.com, www.Jaguarpowersports.com, www.Jlmotorsports.com, www.Powersportsmaxatvs.com, www.Gokartsusa.com, www.Saferwholesale.com, www.Thriftscooters.com, and www.Wholesaleatv.com from May 2020 through March 2022 for between $550 and $2,800.

    Importer(s): EGL Motor Inc., of El Monte, Calif.

    Manufactured In: China

    Note: Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

  • Easter Bunny Necklaces and Boutique Butterfly Jewel Necklaces Recalled Due to High Levels of Cadmium; Imported by Creative Education of Canada

    Recall Date: April 27, 2023

    Recall number: 23-192

    Recall Summary

    Name of Product: Easter Bunny and Boutique Butterfly Jewel Necklaces

    Hazard: The necklaces have high levels of cadmium. Cadmium is toxic if ingested by children and can cause adverse health effects.

    Remedy: Refund

    Consumer Contact: Creative Education of Canada at 800-982-2642 from 8 a.m. to 5 p.m. ET Monday through Friday, email at customerservice@greatpretenders.ca or online at www.greatpretenders.ca and click on “Product Recall” for more information or visit https://shopgreatpretenders.com/pages/product-recall.

    Pictures available here: https://www.cpsc.gov/Recalls/2023/Easter-Bunny-Necklaces-and-Boutique-Butterfly-Jewel-Necklaces-Recalled-Due-to-High-Levels-of-Cadmium-Imported-by-Creative-Education-of-Canada

    Recall Details

    Units: About 4,300

    Description: This recall involves the Easter Bunny Necklace with model number 86140 and the Boutique Butterfly Jewel Necklace with model number 90422 printed on the back of the packaging. The recalled bunny necklaces have a white bunny holding an Easter egg and a gold-colored chain. The recalled butterfly necklaces have blue, pink or purple stones on the butterfly’s wings and a gold-colored chain. They were sold threaded through a white plastic backing. “Great Pretenders” is printed on the tag.

    Remedy: Consumers should immediately stop using the Easter Bunny and Boutique Butterfly Jewel Necklace and contact Creative Education of Canada for a full refund. Consumers should cut the recalled necklace chain in half (with scissors) and provide a photo to the firm as proof of destruction. The firm is contacting all known purchasers.

    Incidents/Injuries: None reported

    Sold At: Toy and gift stores nationwide and online at greatpretenders.ca from January 2023 through March 2023 for about $2 (Easter Bunny necklace) and $4 (Boutique Butterfly Jewel necklace).

    Importer(s): Creative Education of Canada Inc., of Canada

    Manufactured In: China

    Note: Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

  • CPSC Warns Consumers to Immediately Stop Using OKEAH Digital Combination Smoke and Carbon Monoxide Detectors Due to Failure to Alert Consumers to Deadly Carbon Monoxide and Smoke; Sold on Amazon.com

    WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is warning consumers about the risk of carbon monoxide poisoning and smoke inhalation associated with the use of OKEAH combination smoke and carbon monoxide (CO) detectors. The detectors can fail to alert consumers to the presence of hazardous carbon monoxide and smoke.

    More than 200 people in the United States die every year from accidental, non-fire related CO poisoning associated with consumer products. In addition, most fatalities in residential fires are due to smoke inhalation, rather than heat and flames.  In typical residential fire scenarios, there may be as little as one or two minutes to escape after the smoke alarm sounds before the conditions in the home become incapacitating or deadly. More than 2,390 people in the United States die every year from residential structure fires. Furthermore, the risk of dying in a fire is twice as high in homes without a working smoke alarm (1.18 per 1,000), as compared to homes with smoke alarms (0.53 per 1,000).

    If a combination smoke and CO detector that does not alert to the presence of an elevated level of carbon monoxide or smoke is installed in a home, and carbon monoxide or smoke enters the home, the consumer will not be warned of these harmful conditions, making injury or death very likely. Carbon monoxide sensitivity tests performed on the OKEAH detectors by CPSC found that they failed to alert when exposed to pre-determined concentrations of carbon monoxide (400 ppm), in violation of UL 2034, a voluntary safety standard. The smoke sensitivity test performed on the OKEAH detectors by CPSC found that they failed to alert when exposed to pre-determined concentrations of smoke, in violation of UL 217, a voluntary safety standard.

    The combination detectors are made of white plastic and measure about 4 x 1.5 x 4 inches, featuring a digital display. The combination detectors are advertised to detect dangerous levels of carbon monoxide and smoke and alert with a flashing red LED and a loud alarm pattern. Model No. YJ-901 was sold under the Amazon ASIN B097B63W44 on Amazon.com for between $25 and $75. 

    CPSC urges consumers not to purchase or sell these combination smoke and CO detectors. Stop using them and dispose of these products immediately and install new, working CO detectors. Report a dangerous product or a product-related injury on www.SaferProducts.gov.

    Note: Consumers should install combination smoke and CO detectors on each level of their homes and outside separate sleeping areas. Combination smoke and CO detectors should be battery operated or have battery backup. Test combination smoke and CO detectors frequently and replace batteries as needed. Consumers should only buy combination smoke and CO detectors that meet both the UL 2034 and UL 217 safety standards.

    Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

  • CPSC Warns Consumers to Immediately Stop Using PETRICOR, VARWANEO, and WJZTEK Combination Smoke and Carbon Monoxide Detectors Due to Failure to Alert Consumers to Deadly Smoke; Sold on Amazon.com

    WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is warning consumers about the risk of smoke inhalation associated with the use of PETRICOR, VARWANEO, and WJZTEK combination smoke and carbon monoxide (CO) detectors. The detectors can fail to alert consumers to the presence of hazardous smoke.

    Most fatalities in residential fires are due to smoke inhalation, rather than heat and flames. In typical residential fire scenarios, there may be as little as one or two minutes to escape after the smoke alarm sounds before the conditions in the home become incapacitating or deadly. More than 2,390 people in the United States die every year from residential structure fires. Furthermore, the risk of dying in a fire is twice as high in homes without a working smoke alarm (1.18 per 1,000), as compared to homes with smoke alarms (0.53 per 1,000).”

    If a combination smoke and CO detector that does not alert to the presence of an elevated level of carbon monoxide or smoke is installed in a home, and carbon monoxide or smoke enters the home, the consumer will not be warned of these harmful conditions, making injury or death very likely. Smoke sensitivity tests performed on the PETRICOR, VARWANEO, and WJZTEK detectors by CPSC found that they failed to alert when exposed to pre-determined concentrations of smoke, in violation of UL 217, a voluntary safety standard.

    The combination detectors are made of white plastic, with approximate dimensions of 4 x 1.5 x 4 inches. The PETRICOR and VARWANEO models feature a digital display. The PETRICOR and WJZTEK models feature a label on the back which lists the model number. The combination detectors are advertised to detect dangerous levels of smoke or carbon monoxide and alert with a flashing red LED and a loud alarm pattern. Model No. MQ-808 was sold under the Amazon ASIN B09DPPFJZJ; and Model No. ACJ-512COM was sold under the Amazon ASIN B0928QZ21C; and Model No. KT-X3 was sold under the Amazon ASIN B07QVC2722 and B07M8LR9M7. The combination smoke and CO detectors were sold on Amazon.com for between $15 and $53. 

    CPSC urges consumers not to purchase or sell these combination smoke and CO detectors. Stop using them and dispose of these products immediately and install new, working CO detectors. Report a dangerous product or a product-related injury on www.SaferProducts.gov.

    Note: Consumers should install combination smoke and CO detectors on each level of their homes and outside separate sleeping areas. Combination smoke and CO detectors should be battery operated or have battery backup. Test combination smoke and CO detectors frequently and replace batteries as needed. Consumers should only buy combination smoke and CO detectors that meet both the UL 2034 and UL 217 safety standards.

    Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

  • CPSC Report Finds 37 Percent Spike in Child Poisoning Deaths in 2021

    March 20, 2023

    From https://www.cpsc.gov/Newsroom/News-Releases/2023/CPSC-Report-Finds-37-Percent-Spike-in-Child-Poisoning-Deaths-in-2021

    Unintentional pediatric poisoning deaths spiked 37 percent in 2021, with 59 children under five years old losing their lives after gaining access to prescribed or illicit drugs. The U.S. Consumer Product Safety Commission (CPSC) encourages consumers to safeguard their families, especially those more vulnerable, from poisonings by taking control of potentially harmful household products, medications and drugs.

    This National Poison Prevention Week (March 20-24, 2023) marks 61 years since the first national observation. Child poisoning deaths have fallen by 73 percent since 1972 due to tough federal laws including the Poison Prevention Packaging Act (PPPA) of 1970 and the Child Nicotine Poisoning Prevention Act of 2015 and the cooperation of the poison prevention community. This community includes the American Association of Poison Control Centers, standard development organizations, consumer advocates, medical professionals, industry and government. 

    “Sadly, this report shows the work that still needs to be done to protect children,” said Alexander Hoehn-Saric, Chair of the U.S. Consumer Product Safety Commission. “Nearly eight out of 10 poisonings occurred in the home. Please take the time to store cleaning supplies, laundry packets, button batteries, and drugs out of children’s reach or in locked cabinets.  If you see it lying around, a child can grab and swallow it.” 

    CPSC’s latest report notes that African American children suffer a higher rate of unintentional pediatric poisoning injuries, 21.4 percent, compared to being 15.8 percent of the U.S. population. The report also found that blood pressure medications, acetaminophen, antidepressants, laundry packets and bleach are the five products most involved in unintentional pediatric poisonings.

    CPSC encourages family members and caregivers to identify hazards in the home that could be a poisoning danger and keep them out of a child’s sight and reach. 


    Safety tips for parents and caregivers:

    Drugs or Medications

    • Keep medications safely stored in a locked cabinet or box and out of the reach of children.
    • Keep medicines in their original child-resistant containers and never in unsecured containers.
    • Properly discard unfinished or unused medicines.

    Laundry Packets

    • Store laundry packets in their original containers and out of a child’s sight and reach.
    • Do not let children handle laundry detergent packets.

    Household Cleaning Supplies

    • Keep chemicals and cleaning supplies safely stored in a locked cabinet or box and out of the reach of children.
    • Keep household chemicals in their original child-resistant containers.

    Button Cell or Coin Batteries

    • Keep products with accessible batteries away from children if the battery compartments do not have a screw closure or if the compartment is damaged. 
    • Check the toys in your home to make sure battery compartments are secured.
    • Do not allow children to play with or be in contact with button cell or coin batteries.

    Individual Commissioners may have statements related to this topic.  Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.

    Release Number: 23-162