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Hospital
Updated: April 7, 2021 12:00 PM
Covid-19 OSHA Complaint, Mercy Medical Center, 271 Carew Street, SPRINGFIELD, MA, 01104, USA
Mercy Medical Center, 271 Carew Street, SPRINGFIELD, MA, 01104, USA
April 7, 2021 12:00 PM
“Employees working at 271 Carew Street Springfield, MA are exposed to the hazards associated with COVID 19 due to: 1. Employer has not provided a supervisor or other designated employee to fill shortages of PPE including but not limited to N95 respirators once the ready supply has been either deplete... See Mored or a needed size is unavailable. The shortages exist on late night shifts and weekends, when senior staff levels are lower. 2. Employer is providing respiratory protection in the form of N95 respirators which are different makes, models, and sizes than the respirators that employees were originally fit tested for and has failed to provide current fit testing for the new models (most specifically 3M model 8210). 3. Employer has developed an infection control plan for respiratory viruses to include but not limited to COVID 19 and tuberculous; however, the employer has failed to fully implement the program in areas including but not limited to timely notification of a work related exposure.
Alleged Hazards: 3, Employees Exposed: 200
Source: Osha.gov | Receipt Date: 2021-03-10 See Less”
Helpful
Covid-19 OSHA Complaint, Alta Bates Summit Medical Center, 350 Hawthorne Ave., OAKLAND, CA, 94609, USA
Alta Bates Summit Medical Center, 350 Hawthorne Ave., OAKLAND, CA, 94609, USA
April 7, 2021 12:00 PM
“1. The employer is failing to maintain their respiratory protection program. The employer is failing to ensure that employees use the proper respiratory protection in the workplace where respirators are necessary to protect the health of the employee. The employer is failing to adhere to an employee... See More's medical doctor's note (02/01/2021) that the employee shall be able to use a PAPR per his request of areas in the hospital instead of an N95 due to his medical condition in relation to possible exposure to COVID-19 in the workplace. T8 CCR 5144(c)(1) and 5144(e )(6)(A) 2. The employer is failing to maintain their respiratory protection program in that certain program elements may be required for voluntary use to prevent potential hazards associated with the use of the respirator. The employer has approved an employee to use a PAPR but is not allowing the employee to use his own, which would ensure prevention of potential hazards, such as cross contamination from one employee to another and risk possible COVID-19 exposure. The employee does have a 3M 300 NIOSH-approved PAPR and does not trust the employer that a shared PAPR would be cleaned properly for use between multiple employees. T8 CCR 5144(c) and 5144(h)(1)(B)
Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-10 See Less”
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Covid-19 OSHA Complaint, Evergreen Family Medicine PC, 2570 NW Edenbower Blvd Ste 100, ROSEBURG, OR, 97470, USA
Evergreen Family Medicine PC, 2570 NW Edenbower Blvd Ste 100, ROSEBURG, OR, 97470, USA
April 7, 2021 12:00 PM
“Serious
Alleged Hazards: 1,
Source: Osha.gov | Receipt Date: 2020-12-14 See Less”
Helpful
Covid-19 OSHA Complaint, Encompass Health Rehabilitation Hospital of San Juan, University District Hospital, SAN JUAN, PR, 00936, USA
Encompass Health Rehabilitation Hospital of San Juan, University District Hospital, SAN JUAN, PR, 00936, USA
April 7, 2021 12:00 PM
“The employer does not follow the protocol identified in his Exposure Control plan when employees left positive to Covid-19. The employer did not train employees in their Exposure Control Plan. Little protective equipment Lack of cleaning and disinfection in the work area. They don't have a negative... See Morepressure area.
Alleged Hazards: 5, Employees Exposed: 20
Source: Osha.gov | Receip Date: 2020-09-15 See Less”
Helpful
Covid-19 OSHA Complaint, Kaiser Permanente, 2500 Merced Street, SAN LEANDRO, CA, 94577, USA
Kaiser Permanente, 2500 Merced Street, SAN LEANDRO, CA, 94577, USA
April 7, 2021 12:00 PM
“The employer failed to follow proper ATD work procedures by allowing a family member of a patient, who identified themselves as being COVID-19 positive during check in, to spend 4 hours in the ICU visiting a patient. T8 CCR 5199(e)(5)(A) & (B)
Alleged Hazards: 1, Employees Exposed: 1
Source: Osha... See More.gov | Receipt Date: 2021-02-24 See Less”
Helpful
Covid-19 OSHA Complaint, EVERGREEN HOSPITAL MEDICAL CEN, 12040 Ne 128th St, KIRKLAND, WA, 98034, USA
EVERGREEN HOSPITAL MEDICAL CEN, 12040 Ne 128th St, KIRKLAND, WA, 98034, USA
April 7, 2021 12:00 PM
“1. RNs in Cardiovascular Health & Wellness (aka Cardiac & Pulmonary Rehabilitation) do not have access to N95s and are not fit-tested for N95s. These would be required to safely administer CPR and manual ventilation prior to intubation. CNO PII refused to authorize use of N95s; as of 9/2/2020 Evergr... See Moreeen Health had 86,240 respirators on hand. 2. Untimely COVID19 testing of patients and staff. Symptomatic patients are admitted without testing, which has resulted in inadequate infection control. Additional Complaint Received 12/7/2020: 3. Worker tested positive for COVID 2 days after exposing colleagues. Colleagues were not notified of exposure.
Source: Osha.gov | Receipt Date: 2020-09-15 See Less”
Helpful
Covid-19 OSHA Complaint, Advance Community Health, 1011 Rock Quarry Road, RALEIGH, NC, 27610, USA
Advance Community Health, 1011 Rock Quarry Road, RALEIGH, NC, 27610, USA
April 7, 2021 12:00 PM
“1. Employees could be exposed to the COVID-19 virus at the workplace, due to: a) A thermometer is no longer being provided for employees to check their body temperature on entry to the building; b) Employees are coming to work when they are sick. 2. Employees have experienced symptoms, at work, incl... See Moreuding breathing issues, allergy-like symptoms, and headaches, and, since there are brown stains and some kind of growth on the ceiling in places, apparently due to a leak above, there is concern that the symptoms could be due to exposure to mold.
Source: Osha.gov | Receipt Date: 2021-03-02 See Less”
Helpful
Covid-19 OSHA Complaint, Kaiser Foundation Health Plan Inc., 1 Quality Drive, VACAVILLE, CA, 95688, USA
Kaiser Foundation Health Plan Inc., 1 Quality Drive, VACAVILLE, CA, 95688, USA
April 7, 2021 12:00 PM
“The employer did not ensure to implement and maintain an effective procedure for reducing the risk of transmitting aerosol transmissible diseases by allowing employees with a suspected exposure to a COVID-19 case continue to work prior to receiving a negative test. T8 CCR 5199(e)(1).
Alleged Hazard... See Mores: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-04 See Less”
Helpful
Covid-19 OSHA Complaint, MC INDIGO URGENT CARE CENTER, 31861 Gateway Center Blvd S, FEDERAL WAY, WA, 98003, USA
MC INDIGO URGENT CARE CENTER, 31861 Gateway Center Blvd S, FEDERAL WAY, WA, 98003, USA
April 7, 2021 12:00 PM
“Providers at 20 Indigo Urgent Care facilities (from Lake Stevens to Tumwater) are conducting Covid 19 testing on hundreds of patients per day. They are not being provided N95 respirators when providing this testing.
Source: Osha.gov | Receipt Date: 2020-11-09 See Less”
Helpful
Covid-19 OSHA Complaint, UW Health Clinic, 1 South Park, MADISON, WI, 53715, USA
UW Health Clinic, 1 South Park, MADISON, WI, 53715, USA
April 7, 2021 12:00 PM
“6th Floor ENT Clinic 1) Social distancing not being followed, nurses sitting within 6 feet of each other. 2)Employees are not trained on the cleaning (new) solution used. 3)There is minimal deep cleaning and/or cleaning. 4)Patients are coming in without any COVID19 screenings potentially exposing em... See Moreployees to COVID19. 5)Staff do not have appropriate PPE (masks and gloves) that provides protection against COVID19. 6) Employees do not understand how to clean the scopes used on patients.
Alleged Hazards: 6, Employees Exposed: 10
Source: Osha.gov | Receipt Date: 2021-01-13 See Less”
Helpful
Recent Interesting Reports
Johnson&Johnson vaccine, Kansas City, KS, USA
Kansas City, KS, USA
April 9, 2021 3:15 PM
“I got the j&j vac at 1:00pm its been 1 hour so far only a slight tingling on vaccination spot other than that nothing big hoping for the best See Less”
Helpful
1 person found this review helpful
April 6, 2021 10:19 PM
“Got the JnJ vaccine Monday morning 4/5/21 at Wegman’s Bridgewater. Other than my arm being a little sore I have no side effects at all. No head aches, no fevers, nothing! SIDE NOTE: I took a COVID test a few days before to confirm I was COVID free before getting vaccinated. I was on Claritin from th... See Moree night before because allergy season has officially started. I didn’t want the Moderna or Pfizer... not a fan of the lipid MRNA. - Stay Safe guys! See Less”
Helpful
March 29, 2021 10:43 PM
“First injection:
No issues with injection and no side effects.
Second injection:
Immediately following injection, blood ran down my arm. They claimed that a vein was punctured, but that the vaccination went in just fine. I questioned them again to make sure. And they insisted it was fine. The f... See Moreirst night following injection, my body was uncomfortable and I was unable to get into a deep sleep. 24hrs after injection, the injection site was surrounded by a large patch of red skin that was hot to the touch. At 28 hours, fatigue and malaise set in. At 48hrs, I felt markedly better, although still fatigued. The injection site was much less inflamed. See Less”
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March 25, 2021 11:00 AM
“Company name: Zydus Pharmaceuticals Inc.
Brand name: Zydus Pharmaceuticals
Product recalled: Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials
Reason of the recall: Due to Crystalization
FDA Recall date: March 25, 2021
Recall details: Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. i... See Mores voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.
Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.
To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall. Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.
The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000155. Expiry Date: Dec 2021. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000156. Expiry Date: Jan 2022. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000126. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000127. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 [Call: 1-855-671-5023] Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.
Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 [Call: 1-877-993-8779] or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 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.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful
1 person found this review helpful
April 6, 2021 5:00 PM
“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.
The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.
Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. 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.
Check the full recall details on fda.gov
Source: FDA See Less”
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March 31, 2021 10:00 AM
“Company name: Ummzy LLC
Brand name: Thumbs Up 7, Shogun, Krazy Night
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil, Tadalafil, Vardenafil
FDA Recall date: March 31, 2021
Recall details: Palisades Park, NJ, Ummzy LLC is voluntarily r... See Moreecalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil sildenafil & Vardenafil. Tadalafil, Sildenafil & Vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of Tadalafil Sldenafil & Vardenafilin Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
Consumers with underlying medical issues who take Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared Tadalafil Sildenafil & Vardenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.
Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Ummzy LLChas not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box containing 10 capsules. The affected lot numbers of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night includes all lots. Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night was distributed nationwide in the USA via internet and fulfilled by amazon at www.amazon.com.
On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Ummzy LLC is notifying its customers by this press announcement and via e-mail of this recall.
Consumers that have Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Ummzy LLC by phone at 201-416-9325 Monday to Friday from 9AM to 5PM or e-mail ysknabe75@gmail.com. For more information, please visit www.ummzyllc.com.
Consumers should contact their physicians 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less”
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March 24, 2021 4:00 PM
“Company name: Alembic Pharmaceuticals, Inc.
Brand name: Alembic
Product recalled: Telmisartan Tablets, USP, 20 mg
Reason of the recall: Incorrect Product Strength on Label
FDA Recall date: March 24, 2021
Recall details: Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling on... See Moree lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.
Risk Statement: Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall. The product is used for the treatment of hypertension i.e. to lower blood pressure and is packaged in a bottle of 30 tablets having NDC Number 62332-087-30.
The affected lot of Telmisartan Tablets, USP, 20 mg is the lot number 1905005661 and the lot expires in March 2022. The wrong product can be identified by checking the shape and embossing details on the tablets i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped White to off-white tablets debossed with L203 on one side instead of correct product i.e. round shaped White to off-white tablets debossed with L 202 on one side. Telmisartan Tablets, USP, 20mg, Lot No. 1905005661 was distributed Nationwide in the USA to wholesalers, retailers, and pharmacies.
Alembic Pharmaceuticals Limited is notifying its distributors and retailers through letter and is arranging for return of the recalled lot. Consumers that may have Telmisartan Tablets, USP, 20 mg which is being recalled should not discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase. Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc by phone at +1 908-552-5839 (9:00 am – 5:00 pm, EDT, Monday through Friday) or email address david.cobb@alembicusa.com.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful
1 person found this review helpful
April 1, 2021 12:02 PM
“Company name: NANA Collection LLC
Brand name: PremierZen Platinum 5000, Triple SupremeZen Gold 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: April 01, 2021
Recall details: NANA Collection LLC is v... See Moreoluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared Tadalafil and Triple SupremeZen 3500 to contain undeclared Tadalafil and Sildenafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.
The presence of Tadalafil and Sildenafil in PremierZen Platinum 5000 & Triple SupremeZen Gold 3500 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Consumers with underlying medical issues who take PremierZen Platinum 5000 with Tadalafil and Triple SupremeZen Gold 3500 with undeclared Tadalafil and Sildenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.
Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NANA Collection LLC has not received any reports of adverse events related to this recall. This tainted PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 are marketed as dietary supplements for male sexual enhancement and are packaged in paper packaging with a pill blister, 1 capsule per package. The affected PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 lots include all lot numbers to include GATCO 01671, GATCO 1805 with expiration date 12/30/2024. The product can be identified by the word ZEN stamped on the capsule along with PremierZen and Triple SurpremeZen written on the packaging.
PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. NANA Collection LLC is notifying its customers by this press announcement and via email of this recall.
Consumers that have PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 which are being recalled should discard the product. Consumers with questions regarding this recall can contact NANA Collection LLC by 201-773-8545 or nanastyle2014@gmail.com on Monday through Friday from 9am to 5pm, eastern 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. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful
Dream Bone Treats, Scott, AR, USA, Scott, AR, USA
Scott, AR, USA
March 24, 2021 9:25 AM
“My yar old cocker spaniel just had a seizure after giving him 2 dream bone peanut butter treats! Poor lil guy ate 2 of these shitty made in China peanut butter treats! Next thing I see is him convulsing on the floor uncontrollably! Very sad to have to watch! His half sister has been having them for... See More2 years , but it’s gotta be coming from this treat. Do not ever feed your dogs these. I am devasted to now have 2 dogs that have has seizures due to this. See Less”
Helpful
1 person found this review helpful
April 7, 2021 11:00 AM
“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Cliffside Park, NJ, Yol... See Moreo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction.
The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.
Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.
The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.
It also encouraged online marketplaces to ensure these products are not sold on their platforms. Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.
Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful