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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Vaccine, moderna 1st shot. At a Stop and Shop., West Springfield, MA, USA

April 7, 2021 11:08 PM

West Springfield, Massachusetts, United States

Symptoms: Fever Other Soreness

The arm pain wasn't much different than a flu shot. Sore about 2 days. within about 7 hrs had a low grade fever 100.5 took ibuprofen, slept great. Sluggish next day and everything was exhausting. No more fever

Reported By SafelyHQ.com User

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My covid vaccine Pfizer experience, Fresno, CA, USA

Symptoms: Other Headache Swelling Sweating Body Ache Soreness
Fresno, CA, USA

April 21, 2021 10:20 PM

“First shot had some minor pain in injection site and small headache a few hours after shot, no other effects. Second shot was administered 845 a.m. I developed a headache 4 to 5 hours after, around 3 in the afternoon I started noticing pain in my arm kind of feel like my arm was a balloon but there... See Moreis no swelling just warm end a little pain that turned into me noticing my entire body was aching. Didn't get much sleep that night I noticed I had night sweats. Woke up in morning no longer had a headache or body pain See Less
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My Moderna Experience, Toronto, Ontario, Canada

Symptoms: Headache Fatigue Soreness
Toronto, Ontario, Canada

April 22, 2021 5:57 PM

“- Never had COVID-19 before
- DAY 1 - Lined up at a pop-up clinic on Sunday April 18th starting at 7:30AM. Got the Moderna shot at 1:15PM. Left the clinic at 1:30PM. Total = 6 hours
- The needle didn't hurt much but my arm started feeling sore after 3 hours
- Got home feeling really tired and too... See Morek a nap (don't know if it was due to the vaccine or from lining up all day)
- DAY 2 - Still very tired. Arm still store. I felt tingling in my hands, feet, and legs. I felt REALLY nervous because I was diagnosed with Miller-Fisher Syndrome back in 2012 (which is a rare variant of Guillain-Barre Syndrome). Had a headache all day despite taking a 1.5 hour nap. Went to bed early
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1st Pfizer Covid Vaccine, New York City, NY, USA

Symptoms: Nausea Soreness
New York City, NY, USA

April 22, 2021 6:23 PM

“48 yo female. On the day in which I got the shot I did not feel any pain at the injection site. I went home and felt great. The day after I woke up feeling great, with just mild soreness in my arm. I worked out and I began to feel a bit nauseous. I took pepto Bimol and felt better. The day after I w... See Moreas nauseous on the first part of the day. See Less
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Covid-19 OSHA Complaint, Mercier Carpet Service, Inc, 1343 Riverdale St., WEST SPRINGFIELD, MA, 01089, USA

Mercier Carpet Service, Inc, 1343 Riverdale St., WEST SPRINGFIELD, MA, 01089, USA

March 31, 2021 12:00 PM

“Employees are exposed to health hazard due to owners testing positive for COVID-19


Source: Osha.gov | Receipt Date: 2021-03-02 See Less
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Covid-19 OSHA Complaint, Balise Honda, 400 Riverdale Street, WEST SPRINGFIELD, MA, 01089, USA

Balise Honda, 400 Riverdale Street, WEST SPRINGFIELD, MA, 01089, USA

March 10, 2021 12:00 PM

“1. Employees are at risk of exposure to COVID-19 due to working in proximity to employees waiting for COVID-19 test results or employees who were in close contact with someone who tested positive. 2. Employees are at risk of exposure to COVID-19 due to failing to self-isolate after working in proxim... See Moreity to employees waiting for COVID-19 test results or employees who were in close contact with someone who tested positive. 3. Employees are at risk of exposure to COVID-19 due to lack of social distancing enforcement. 4. Employees are at risk of exposure to COVID-19 due to lack of mask enforcement.


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JOHNSON & JOHNSON COVID-19 Vaccine 03-07-2021, West Springfield, VA, USA

Symptoms: Muscle Pain Soreness
West Springfield, VA, USA

March 9, 2021 5:29 AM

“I received the vaccine Sunday, March 7, 2021, CVS, Beauregard St., Alexandria, VA. No line, no wait. The injection from the needle into my deltoid muscle was painful, but the pain dissipated soon afterwards and I took four 200 mg Advil before bedtime. The ibuprofen alleviated the muscle soreness.... See MoreI’d like to state I don’t consider the injection location a “ side-effect”. So grateful for the J&J one dose COVID-19 vaccine and immunity it provides. Thank you. See Less
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Covid-19 OSHA Complaint, GOODLESS BROTHERS ELECTRIC CO. INC., 100 MEMORIAL DR., WEST SPRINGFIELD, MA, 01089, USA

GOODLESS BROTHERS ELECTRIC CO. INC., 100 MEMORIAL DR., WEST SPRINGFIELD, MA, 01089, USA

February 9, 2021 12:00 PM

“Employees are at risk for exposure to COVID-19 due to: 1. Working in close proximity to other employees, including those who are exhibiting symptoms of COVID-19 while awaiting test results, or employees that have already tested positive for COVID-19. 2. The lack of available disinfection supplies an... See Mored an absence of disinfection policies and procedures. 3. A lack of enforcement of face-covering requirements.

Alleged Hazards: 1, Employees Exposed: 5
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Covid-19 OSHA Complaint, Accotink Academy, 8519 Tuttle Road, SPRINGFIELD, VA, 22152, USA

Accotink Academy, 8519 Tuttle Road, SPRINGFIELD, VA, 22152, USA

February 2, 2021 12:00 PM

“Employer failed to notify employees of their potential COVID-19 exposure to positive coworkers, within 24-hours of their knowledge. Employer is not ensuring that the facility is sanitized properly.

Alleged Hazards: 2, Employees Exposed: 5
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Covid-19 OSHA Complaint, 99 Restaurant, 1053 Riverdale Road, WEST SPRINGFIELD, MA, 01089, USA

99 Restaurant, 1053 Riverdale Road, WEST SPRINGFIELD, MA, 01089, USA

January 13, 2021 12:00 PM

“1. Employees are at risk of exposure to COVID-19 due to lack of mask enforcement. 2. Employees are at risk of exposure to COVID-19 due to working in proximity to employees waiting for COVID-19 test results or employees who were in close contact with someone who tested positive.

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Recent Interesting Reports

After first Moderna shot, Sebastopol, CA, USA

Symptoms: Other Body Ache Soreness
Sebastopol, CA, USA

March 26, 2021 5:51 PM

“Sore arm first night, much like a flu shot. In subsequent days had achy lymph nodes in armpit, neck and upper chest. No big deal, just rather odd. 9 days after shot I woke with first Atrial fib in almost 6 weeks (had second Cardiac ablation last summer that we hoped would "fix" it). I had Afib episo... See Moredes next two nights, decreasing in intensity, but certainly requiring meds and monitoring. Since been diagnosed with Afib bit over 2 years ago had never had it multiple days in a row before.
Since then, every days it's less problematic. Now just an hour of feeling a tad funky in the afternoons.Asked my cardiologist if he'd had other patients with similar reactions and he said "yes", but mostly after second vaccination. Seems as if the inflammation that's triggered by vaccine as body responds and creates antibodies to virus, triggers "twitchy" susceptible heart into freaking out (my language, not his!) Makes me rather dread how I"m going to feel next week after second shot, But will certainly not deter me to get fully covered.
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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
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Reported By SafelyHQ.com User

Modern, Merced County, CA, USA

Symptoms: Other Fatigue
Merced County, CA, USA

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
Reported By SafelyHQ.com User
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March 31, 2021 12:02 PM

“Company name: Nuri Trading LLC
Brand name: Thumbs Up 7, Shogun-X, 69MODE
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil, Tadalafil, Vardenafil
FDA Recall date: March 31, 2021
Recall details: Nuri Trading is voluntarily recalling all... See Morelots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level. FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. Sildenafil,tadalafil, and vardenafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil, tadalafil, and/ or vardenafil in Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules make 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 Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69 capsules with undeclared sildenafil,tadalafil, and/or 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, Nuri Trading 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 blister foil sheets in a box. Each box contains 10 capsules. These products 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.

Nuri Trading LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE Blue 69, which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Nuri Trading by phone at (201) 380-1046 Monday to Friday from 9AM to 5PM eastern time or e-mail nuritrading17@gmail.com. For more information, please visit www.nuritradingusa.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin 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
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Reported By SafelyHQ.com User

April 18, 2021 10:04 AM

“I have 2 sick, A week and a half ago Née bag of Kibbles and bits bistro and the Melody Just started about a week and a half ago now I have two dogs sick one with an IV in the hospital See Less
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Doctor Visit: Yes
Diagnosis: Hospital

April 12, 2021 1:00 PM

“Company name: J. M. Smucker Co.
Brand name: Meow Mix®
Product recalled: Meow Mix® Original Choice Dry Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: April 12, 2021
Recall details: Orrville, OH – The J. M. Smucker Co. today announced a limited, voluntary recal... See Morel of two lots of Meow Mix® Original Choice Dry Cat Food (30LB bag) due to potential salmonella contamination. The Company has received no reports of pet illness or adverse reaction and has issued this recall out of an abundance of caution.

The impacted products were sold at select Walmart stores in IL, MO, NE, NM, OK, UT, WI, and WY. No other Meow Mix® products are impacted by this recall. If pet parents have products matching the following description in their possession, they should stop feeding it to their cats and dispose of it immediately. This information can be found on the bottom and back of each bag.

- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1081804. Best If Used By Date: 9/14/2022
- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1082804. Best If Used By Date: 9/15/2022

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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
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Reported By SafelyHQ.com User

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
Reported By SafelyHQ.com User

March 27, 2021 11:00 PM

“Company name: Midwestern Pet Foods
Brand name: Multiple brands
Product recalled: Dog and Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: March 27, 2021
Recall details: Midwestern Pet Foods, Evansville, Indiana is issuing a voluntary recall of specific expirati... See Moreon dates of certain dog and cat food brands including CanineX, Earthborn Holistic, Venture, Unrefined, Sportmix Wholesomes, Pro Pac, Pro Pac Ultimates, Sportstrail, Sportmix and Meridian brands produced at its Monmouth, Illinois Production Facility because they have the potential to be contaminated with Salmonella. A full list of recalled products may be found at the end of this announcement. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. No human or pet illnesses have been reported to date.

Products were distributed to retail stores nationwide and to online retailers. Lot code information may be found on the back of the bags with the following format: “EXP AUG/02/22/M1/L# See Example Image Below This recall covers only certain products manufactured at Midwestern Pet Foods Monmouth, Illinois facility.  The unique Monmouth Facility identifier is located in the date code as an “M”. The recall was as the result of a routine sampling program by the company which revealed that the finished products may contain the bacteria.

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products.  Retailers are encouraged to contact consumers that have purchased the recalled products if the means to do so exists. Do not feed the recalled products to pets or any other animals.  Destroy the food in a way that children, pets and wildlife cannot access them.  Wash and sanitize pet food bowls, cups and storage containers. 

Always ensure you wash and sanitize your hands after handling recalled food or any utensils that come in contact with recalled food. Contact Midwestern Pet Foods Consumer Affairs at info@midwesternpetfoods.com or 800-474-4163, ext 455 from 8 AM to 5 PM Central Time, Monday through Friday for additional information. This voluntary recall is being conducted in cooperation with the US Food and Drug Administration.  All other Midwestern Pet Foods products are unaffected by this recall.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

March 31, 2021 8:00 PM

“Company name: Apotex Corp.
Brand name: Apotex Corp.
Product recalled: Guanfacine Extended-Release Tablets 2mg
Reason of the recall: Trace amounts of Quetiapine Fumarate
FDA Recall date: March 31, 2021
Recall details: Weston, Florida, Apotex Corp is voluntarily recalling three (3) lots of Guanfa... See Morecine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.

Risk Statement: Administration of Guanfacine Extended-Release Tablets containing trace amounts of Quetiapine Fumarate to a patient can result in the possibility of hypersensitivity reaction and may potentially have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product.

To date, Apotex Corp has not received any reports of adverse events related to this recall. Guanfacine is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be used with other stimulant medications. Quetiapine is indicated for the treatment of Schizophrenia and other serious mental disorders such as Bipolar disorder manic episodes, Bipolar disorder, and depressive episodes.

The affected Guanfacine Extended-Release Tablets can be identified by NDC numbers stated on label of the product. The lot number and Expiration date are located to the left side of the product description on the label besides the 2D barcode. The affected lots were distributed in the USA between December 22, 2020 to March 19, 2021.

- Guanfacine Extended-Release Tablets. Pack Size: 100 Tablets. Strength: 2 mg. NDC Number: 60505-3928-1. UPC Code: 3 60505 39281 0. Lot Number / Expiry Date: RX1662 / Nov-22 | RX1663 / Nov-22 | RX1664 / Nov-22

The three (3) affected lots of Guanfacine extended-release tablets were distributed by Apotex nationwide in the USA to Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group. Apotex Corp is currently notifying its affected direct account Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group, via mail (FedEx Standard Overnight) and is arranging for return of all recalled product.

Patients who have received either of the three impacted lots of Guanfacine Extended-Release Tablets or have questions regarding this recall should contact their pharmacy. Individuals should not interrupt their therapy due to this notice. They should immediately contact their health care provider for medical advice and return the impacted product to Inmar Rx Solutions by contacting at the numbers provided in this press release.

Wholesalers, Distributors, Warehousing Chains, Independent Retail Pharmacy and Retail Buying Group should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-855-697-4722 (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

Consumers with the affected units of Guanfacine Extended-Release Tablets, can contact Inmar Rx Solutions (“Inmar”) at 1-855-697-4722, to receive a recall/return packet including the Recall Stock Response Form, or you may obtain this form clsnetlink.comExternal Link Disclaimer

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am –5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. 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
Reported By SafelyHQ.com User