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Virginia, United States
Updated: April 9, 2021 5:42 PM
Jannssen Johnson & Johnson Vaccine, King and Queen County, VA, USA
Symptoms: Muscle Pain
King and Queen County, VA, USA
April 9, 2021 5:42 PM
“I received my Jannssen vaccination April 4, 2021. 69 black female with diabetes. I only experienced burning if medicine entering the muscle. After that I haven’t had any reactions at all. I been trying to feel the site of vaccination for soreness, but there is none. See Less”
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Covid-19 OSHA Complaint, Imperial Highline of Manassas, 7508 Centreville Road, MANASSAS, VA, 20111, USA
Imperial Highline of Manassas, 7508 Centreville Road, MANASSAS, VA, 20111, USA
April 7, 2021 12:00 PM
“Employer is permitting employees to work despite having COVID-19 symptoms. Employer does not ensure that the workplace is sanitized in regular intervals and between work shifts. Employer has not cleaned and disinfected the areas where three COVID-19 positive employees accessed/worked prior to allowi... See Moreng other employees access to those areas.
Alleged Hazards: 3, Employees Exposed: 15
Source: Osha.gov | Receipt Date: 2021-03-16 See Less”
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Covid-19 OSHA Complaint, Nectar Resaurant & Lounge, 642 S Picket Street, ALEXANDRIA, VA, 22304, USA
Nectar Resaurant & Lounge, 642 S Picket Street, ALEXANDRIA, VA, 22304, USA
April 7, 2021 12:00 PM
“Item No.1: Employees and patrons are not wearing masks. Item No.2: The employer is not ensuring employees social distance when feasible.
Alleged Hazards: 2, Employees Exposed: 15
Source: Osha.gov | Receipt Date: 2021-02-22 See Less”
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Covid-19 OSHA Complaint, North Spring Behavioral Healthcare, Inc., 42009 Victory Lane, LEESBURG, VA, 20176, USA
North Spring Behavioral Healthcare, Inc., 42009 Victory Lane, LEESBURG, VA, 20176, USA
April 7, 2021 12:00 PM
“Item No.1: Employees are not provided adequate personal protective equipment for interactions with patients that are positive for COVID-19. Item No.2: The employer does not have an adequate or consistent supply of disinfectants. Item No.3: The employer is not isolating the residents that have tested... See Morepositive for COVID-19. Item No.4: The employer is allowing employees that are positive for COVID-19 to continue working at the site.
Alleged Hazards: 4, Employees Exposed: 20
Source: Osha.gov | Receipt Date: 2021-02-12 See Less”
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Covid-19 OSHA Complaint, Fusion Logistics, Inc., 5617 Industrial Road, SPRINGFIELD, VA, 22151, USA
Fusion Logistics, Inc., 5617 Industrial Road, SPRINGFIELD, VA, 22151, USA
April 7, 2021 12:00 PM
“Item No.1: The employer does not screen or take employee temperatures prior to the start of the workshift.
Alleged Hazards: 1, Employees Exposed: 20
Source: Osha.gov | Receipt Date: 2020-12-23 See Less”
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Covid-19 OSHA Complaint, Bon Secours Maryview Medical Center, 3636 High Street, PORTSMOUTH, VA, 23707, USA
Bon Secours Maryview Medical Center, 3636 High Street, PORTSMOUTH, VA, 23707, USA
April 7, 2021 12:00 PM
“Located at Bon Secours Maryview Medical Center, on the Psychiatric Unit where two patients recently tested positive to COVID-19, 1. Employees (Nurses, CNA's, Psychiatric Technicians) are not trained on COVID-19 protection protocols for caring for COVID-19 positive patients. 2. COVID-19 positive pati... See Moreents are allowed to leave rooms their rooms and walk around in common areas. These patients are not quarantined to their rooms. 3. No infectious disease/COVID-19 signage or warnings on rooms where COVID-19 patients reside. Believed to be rooms 107 & 113.
Alleged Hazards: 3, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-03-08 See Less”
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Covid-19 OSHA Complaint, Ruby Tuesday Inc, 145 Commonwealth Drive, WYTHEVILLE, VA, 24382, USA
Ruby Tuesday Inc, 145 Commonwealth Drive, WYTHEVILLE, VA, 24382, USA
April 7, 2021 12:00 PM
“Management not wearing mask over mouth or nose.
Alleged Hazards: 1, Employees Exposed: 12
Source: Osha.gov | Receipt Date: 2021-03-08 See Less”
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Covid-19 OSHA Complaint, BGF Industries, Inc., 2074 Dearing Ford Road, Altavista, VA 24517, USA
BGF Industries, Inc., 2074 Dearing Ford Road, Altavista, VA 24517, USA
April 7, 2021 12:00 PM
“The building has not been cleaned by anyone after several positive cases of COVID-19.
Source: Osha.gov | Receipt Date: 2021-02-16 See Less”
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Covid-19 OSHA Complaint, England's Stove Works, 100 Progress Lane, MADISON HEIGHTS, VA, 24572, USA
England's Stove Works, 100 Progress Lane, MADISON HEIGHTS, VA, 24572, USA
April 7, 2021 12:00 PM
“People in this establishment were not wearing cloth face coverings. People in this establishment were not following social distancing guidelines. (Employees and customers) The caller states someone dead this weekend from Covid from England. A lot of people in the 2 locations tested positive for Covi... See Mored.
Alleged Hazards: 2, Employees Exposed: 2
Source: Osha.gov | Receipt Date: 2020-09-30 See Less”
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Covid-19 OSHA Complaint, Choice Waste Services, 11924 Old Stage Road, CHESTER, VA, 23836, USA
Choice Waste Services, 11924 Old Stage Road, CHESTER, VA, 23836, USA
April 7, 2021 12:00 PM
“The employer is not implementing precautions to protect employees from contracting and spreading the Coronavirus (COVID-19) in the workplace: a) After an employee(s) tested positive, employees were not notified in accordance with 16VAC25-220.
Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.... See Moregov | Receipt Date: 2021-03-19 See Less”
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Recent Interesting Reports
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”
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2 people found this review helpful
March 26, 2021 7:00 PM
“Company name: Namoo Enterprise LLC
Brand name: PremierZen
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 26, 2021
Recall details: Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling al... See Morel lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction.
The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. Risk Statement: Consumers with underlying medical issues who take PremierZen Black 5000 with undeclared sildenafil and 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, Namoo Enterprise LLC has not received any reports of adverse events related to this recall. The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in card form with one capsule per card and is aware of at least one lot with an expiration date of December 2023. Each pack is black with gold, blue, white and red text. The capsule appears black and is enclosed within clear plastic on the package. The affected lots of PremierZen Black 5000 includes all lots. PremierZen Black 5000 was sold nationwide in the USA via the internet and fulfilled by ebay at www.ebay.com and also 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. Namoo Enterprise LLC is notifying its customers by this press announcement and by mailing recall letters. Consumers that have PremierZen Black 5000 should stop using and destroy them. Consumers with questions regarding this recall can contact Namoo Enterprise LLC by phone at 201-267-0539, Monday to Friday, 9 A.M. to 5 P.M. EST or email at namooenterprise@gmail.com from Monday to Friday.
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”
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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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April 5, 2021 5:00 PM
“Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall det... See Moreails: Company Announcement Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. 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 sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or 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, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed 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.
Check the full recall details on fda.gov
Source: FDA See Less”
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March 25, 2021 9:01 AM
“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.
Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.
The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.
Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.
The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.
Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.
Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Check the full recall details on fda.gov
Source: FDA See Less”
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1 person found this review helpful
April 4, 2021 6:56 PM
“The CDC announced that they are currently investigating a multistate outbreak of Salmonella infections where 19 people have been reported sick from 8 states (CA, KY, MS, NH, OK, OR, TN, WA). Eight people of the total have required hospitalization but no deaths have been reported to date.
Accordin... See Moreg to the outbreak notice, there are reports of wild songbirds, such as pine siskins (small, streaked, yellow-tinged songbirds in the finch family) sick with the same strain of Salmonella that is making people sick in this outbreak. Salmonella germs can spread between species of birds, to pets, and to people.
You can get sick when you touch your mouth with unwashed hands after touching wild birds, bird feeders or bird baths, or your pets that have contact with wild birds.
CDC advises to:
- Clean and disinfect your bird feeder and bird bath weekly or when they are visibly dirty.
- Do not touch or hand-feed wild birds with your bare hands.
- Always wash your hands with soap and water
- Call your healthcare provider right away if you have any of these severe Salmonella symptoms
Most people infected with Salmonella develop diarrhea, fever, and stomach cramps 6 hours to 6 days after being exposed to the bacteria and the illness usually lasts 4 to 7 days, and many recover without treatment.
Check the CDC website for the full investigation details cdc.gov
Source: CDC See Less”
Doctor Visit: Yes
Diagnosis: Salmonella
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1 person found this review helpful
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”
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1 person found this review helpful
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”
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1 person found this review helpful
March 29, 2021 8:00 PM
“Company name: Antoto-K
Brand name: Thumbs Up 7
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 29, 2021
Recall details: Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 7... See More0K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. 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 Sildenafil and Tadalafil in Thumbs Up 7 Red 70K, 10 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, 10 capsules with undeclared Sildenafil and 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, Antoto-K has 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 foil sheet and a box containing 10 capsules. The affected lot numbers of Thumbs Up 7 Red 70K includes all lots. Thumbs Up 7 Red 70K was 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. Antoto-K is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Thumbs Up 7 Red 70K which is being recalled should stop using and destroy them.
Consumers with questions regarding this recall can contact Antoto-K by email at ngtbtr.k17@gmail.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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1 person found this review helpful
Blackcass.com chainsaw, scam, Denver, CO, USA
Denver, CO, USA
March 23, 2021 5:59 PM
“All I received was the chain and straps not the chain saw how can I get my money back? I am 73 and got cheated out of $29.99 plus tax for a chain saw when all I received was a chain and I want my money back See Less”
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2 people found this review helpful