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Alabama, United States

Updated: April 7, 2021 12:00 PM

Covid-19 OSHA Complaint, Alabama Clinics, 2812 Hartford Hwy, Dothan, AL 36305, USA

Alabama Clinics, 2812 Hartford Hwy, Dothan, AL 36305, USA

April 7, 2021 12:00 PM

“1. The employer requires employees to perform work near dead birds; exposing employees to infectious diseases and other health hazards in the COVID19 (coronavirus) Testing Site of the facility. 2. The employer requires employees to perform work at or near black mold; exposing employees to respirator... See Morey hazards and other health hazards in the COVID19 Testing Site of the facility.

Alleged Hazards: 2, Employees Exposed: 50
Source: Osha.gov | Receipt Date: 2021-03-18
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Pathway Healthcare LLC, 1000 Urban Center Drive, Birmingham, AL 35242, USA

Pathway Healthcare LLC, 1000 Urban Center Drive, Birmingham, AL 35242, USA

April 7, 2021 12:00 PM

“1. Employer is exposing workers to possible health hazards from COVID 19 by not enforcing facial covering protocol in the administration office. 2. Employer is exposing workers to possible health hazards from COVID 19 by not enforcing on social distancing.

Alleged Hazards: 2, Employees Exposed:... See More35
Source: Osha.gov | Receipt Date: 2021-03-05
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Mayfield Ice Cream of Birmingham, 126 Barber Ct., BIRMINGHAM, AL, 35209, USA

Mayfield Ice Cream of Birmingham, 126 Barber Ct., BIRMINGHAM, AL, 35209, USA

April 7, 2021 12:00 PM

“In the warehouse and freezer area employees may be exposed to health hazards from COVID-19 because: 1. employees may have tested positive for COVID-19 and the employer may not be cleaning or sanitizing the work area to reduce employee exposure. 2. the employer may not be adequately enforcing social... See Moredistancing guidelines. 3. sinks used for sanitizing and/or disinfecting hands may not provided with hot/warm water.


Source: Osha.gov | Receipt Date: 2020-08-19
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Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

Covid-19 OSHA Complaint, Thumpers Performance & Exhaust, LLC, 15930 York Lane, ATHENS, AL, 35611, USA

Thumpers Performance & Exhaust, LLC, 15930 York Lane, ATHENS, AL, 35611, USA

April 7, 2021 12:00 PM

“1. Employees exposed to slip hazards due to oil being on the garage floor. 2. Employees potentially exposed to COVID-19 due to other employees testing positive to COVID-19 and allowed to continue to come to work.

Alleged Hazards: 2, Employees Exposed: 2
Source: Osha.gov | Receipt Date: 2020-07-20 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Southern Plastics Company, Inc., 2 HUMMINGBIRD LANE, EUFAULA, AL, 36027, USA

Southern Plastics Company, Inc., 2 HUMMINGBIRD LANE, EUFAULA, AL, 36027, USA

April 1, 2021 12:00 PM

“1. The employer requires that employees conduct maintenance activities such as mold change out without ensuring that procedures to control the energy sources were utilized by employees exposing employees to crush-by hazards. 2. The employer requires employees not to lock out heat exchangers with saf... See Moreety chains for the injection mold machines during service and maintenance; exposing employees to crush-by hazards. 3. The employer requires that employees conduct maintenance activities such as mold change out without providing locks to those employees to control the energies such as electric and pneumatic at the injection machines exposing employees to crush-by hazards. 4. The employer requires that employees conduct maintenance activities such as mold change out and failing to certify the training needed for authorized employees as is required by the standard exposing employees to crush-by hazards. 5. The employer requires employees to use air nozzles at +100psi without a safety nozzle protection in the injection machine area; exposing employees to air puncture hazards. 6. The employer requires employees to work and walk in oil, grease and other materials spilled on the floor; exposing employees to slipping hazards in the production area. 7. The employer fails to ensure periodic cleaning of the facility in accordance to CDC (Center for Disease Control and Prevention) guidelines for the COVID-19 pandemic.

Alleged Hazards: 7, Employees Exposed: 150
Source: Osha.gov | Receipt Date: 2021-03-15
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Tallassee Automotive, 1618 Gilmer Avenue, TALLASSEE, AL, 36078, USA

Tallassee Automotive, 1618 Gilmer Avenue, TALLASSEE, AL, 36078, USA

April 1, 2021 12:00 PM

“1) Employees are exposed to health hazards related to the employer not cleaning and sanitizing the workplace regularly per CDC (Center for Disease Control and Prevention) guidelines after employees tested positive for COVID-19. 2)Employees are exposed to health hazards in that the employer is allowi... See Moreng employees who have tested positive for COVID-19 to work with symptoms of the virus, such as fever.

Alleged Hazards: 2, Employees Exposed: 10
Source: Osha.gov | Receipt Date: 2021-03-09
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, AutoZone Auto Parts, 407 Holcombe Avenue, MOBILE, AL, 36606, USA

AutoZone Auto Parts, 407 Holcombe Avenue, MOBILE, AL, 36606, USA

April 1, 2021 12:00 PM

“1. Employees are exposed to health hazards from the COVID-19 virus in that the employer does not sanitize the facility regularly per CDC (Center for Disease Control and Prevention) guidelines. 2. Employees are exposed to health hazards in that the employer is not ensuring that soap and towels are pr... See Moreovided in the restroom. 3. Employees are exposed to health hazards in that the employer is not ensuring disinfecting chemicals are used in the mop water. 4. Employees are exposed to health hazards in that the employer is not ensuring that trash is disposed of promptly and properly and allowing it to accumulate in the back storage area.

Alleged Hazards: 4, Employees Exposed: 10
Source: Osha.gov | Receipt Date: 2021-03-08
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Central Alabama Wood Products, LLC, 6887 Hwy 9, EQUALITY, AL, 36026, USA

Central Alabama Wood Products, LLC, 6887 Hwy 9, EQUALITY, AL, 36026, USA

April 1, 2021 12:00 PM

“1) Employees are exposed to infectious disease such as COVID-19 in that the employer fails to require and enforce the use of face coverings by employees per CDC guidelines. 2) Employees are exposed to infectious disease such as COVID-19 in that the employer fails to implement methods or practices to... See Moreclean and sanitized commonly used equipment and surfaces after an employee has tested positive for COVID-19. 3) Employees are not provided hand sanitizing material or wipes to protect themselves from COVID-19.


Source: Osha.gov | Receipt Date: 2021-02-11
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Adullam House Thrift Store, 26 Firetower Rd, WETUMPKA, AL, 36093, USA

Adullam House Thrift Store, 26 Firetower Rd, WETUMPKA, AL, 36093, USA

April 1, 2021 12:00 PM

“1) Employees are exposed to infectious disease in that the employer does not enforce the 6 ft. social distancing requirement per CDC guidelines in that the employer does not limit the amount of customers that can enter the store at one time and the employer does not provide shielding (sneeze guards)... See Morein between employees and customers that are required to work in close proximity. 2) Employees are exposed to health hazards associated with COVID-19 in that the employer does not require employees and visitors to wear masks per CDC (Center for Disease Control and Prevention) guidelines. 3) Employees are exposed to health hazards related to the employer not informing them of when other employees have tested positive for COVID-19 (coronavirus disease) within the facility as in accordance to CDC (Center for Disease Control and Prevention) guidelines. 4) Employees are exposed to health hazards related to the employer not cleaning and sanitizing the workplace regularly per CDC (Center for Disease Control and Prevention) guidelines after employees tested positive for COVID-19. 5) Employees are exposed to health hazards in that the employer is allowing employees who have tested positive for COVID-19 to work with symptoms of the virus, such as fever.

Alleged Hazards: 5, Employees Exposed: 28
Source: Osha.gov | Receipt Date: 2021-01-05
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Twitchell, Inc., 4031 Ross Clark Circle, DOTHAN, AL, 36304, USA

Twitchell, Inc., 4031 Ross Clark Circle, DOTHAN, AL, 36304, USA

April 1, 2021 12:00 PM

“1) Employees are exposed to health hazards from the COVID-19 virus in that the employer does not require employees to social distance per CDC (Center for Disease Control and Prevention) guidelines. 2) Employees are exposed to health hazards associated with COVID-19 in that the employer does not requ... See Moreire employees and visitors to wear masks per CDC (Center for Disease Control and Prevention) guidelines. 3) Employees are exposed to health hazards related to the employer not informing them of when other employees have tested positive for COVID-19 (coronavirus disease) within the facility as in accordance to CDC (Center for Disease Control and Prevention) guidelines. 4) Employees are exposed to health hazards in that the employer is allowing employees who have tested positive for COVID-19 to work with symptoms of the virus, such as fever. 5) Employees are exposed to health hazards associated with COVID-19 in that the employer does not screen employees for symptoms of the virus per CDC (Center for Disease Control and Prevention) guidelines.

Alleged Hazards: 5, Employees Exposed: 400
Source: Osha.gov | Receipt Date: 2021-01-04
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Reported By SafelyHQ.com User

Recent Interesting Reports

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
Reported By SafelyHQ.com User

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
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Reported By SafelyHQ.com User

March 16, 2021 5:00 PM

“Company name: Bravo Packing, Inc.
Brand name: Bravo Packing, Inc.
Product recalled: Pet food: Performance Dog, beef, green tripe, and bone
Reason of the recall: Due to Potential Salmonella and Listeria monocytogenes
FDA Recall date: March 16, 2021
Recall details: Bravo Packing, Inc. of Carneys... See MorePoint, NJ is expanding the previously announced voluntary recall of two pet food products to now include all pet food and bones in all package sizes. During an FDA inspection, samples collected tested positive for Salmonella and Listeria monocytogenes and resulted in a recall due to the potential health risks to humans and pets.  Bravo Packing, Inc. is expanding the recall due to potential cross contamination.

No human or animal illnesses related to the identified products have been reported to date. Bravo Packing Inc. generally works with distributors that fill orders to retail stores and to consumers directly nationwide. Consumers with any of the affected products should handle them with caution, discard products in a secure container, and wash hands and surfaces properly. Consumers with questions should contact Bravo Packing, Inc. at 856-299-1044 (Monday – Friday, 9:00 AM-2:00 PM, EST). Recalled Products:

- “Performance Dog” (chub) frozen raw dog food (2 lbs.)
- “Performance Dog” (chub) frozen raw dog food (5 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (2 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (5 lbs.)
- “Beef” (chub - ground) frozen raw dog food (2 lbs.)
- “Beef” (chub - ground)frozen raw dog food (5 lbs.)
- “Performance Dog” (patties) frozen raw dog food (unknown)
- “Tripe” (patties ¼ lbs.) frozen raw dog food (unknown)
- Bones (smoked) 14 varieties (unknown)

Salmonella can cause illness in pets eating the products, as well as people who handle contaminated pet food products, especially if they have not thoroughly washed their hands after having contact with the products, infected pets, or any surfaces exposed to these products. 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 (an infection of the heart muscle), arthritis, muscle pain, eye irritation, and urinary tract symptoms. People who have these symptoms after having contact with the products identified in this recall or with a pet that has eaten these products should contact their healthcare providers.

A pet with a Salmonella infection may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have decreased appetite, fever, and abdominal pain. If your pet has consumed the recalled products and has these symptoms, please contact your veterinarian. Pets exposed to contaminated food can be infected without showing symptoms. Infected pets, including those without symptoms, can also shed Salmonella through their feces and saliva, spreading pathogens into the home environment and to humans and other animals nearby.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

Pfizer vaccine 1st dose, CVS, Bagdad Road, Cedar Park, TX, USA

Symptoms: Soreness
CVS, Bagdad Road, Cedar Park, TX, USA

March 22, 2021 9:18 AM

“Arrived on time, just 4 people ahead of me, the line moved fast. I was out in about 20 minutes. They were well organized. It is now around 15 hours later and zero side effects, apart from some soreness at the injection site, similar to a flu shot. See Less
Reported By SafelyHQ.com User

April 2, 2021 8:00 PM

“Company name: A-S Medication Solutions, LLM
Brand name: A-S Medication Solutions, LLM
Product recalled: Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana
Reason of the recall: Products contain an incomplete prescription drug lab... See Moreel
FDA Recall date: April 02, 2021
Recall details: Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.

Risk Statement: Use of acetaminophen could be potentially harmful if safety warnings contained on the OTC label are not observed including: liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient. To date, the Company has not received any reports of adverse events related to this recall.

The product is used as a pain and fever reliever. The 100-count bottles labeled with NDC 50090-5350-0 are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between 1/14/21 and 3/15/21 nationwide in the USA. Expiration dates are either 7/31/22 or 8/31/22. The affected bottles that should be returned contain a short Rx drug label that lacks the full OTC Drug Facts chart.

ASM is also notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have this product which is being recalled should stop using it and return it in preaddressed return mailers that will be provided by ASM or the distributors.

Consumers with questions regarding this recall can contact ASM by telephone at 847.680.3515 x 236, from 9-5 p.m. CST, or e-mail at anel.figueroa@a-smeds.com. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using this or any 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.

NDC # 50090-5350-0 Lot #s 323206, 323207, 323208, 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335365, 335366, 33536, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377, 335395, and 352116.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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
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
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Reported By SafelyHQ.com User

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
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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
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Reported By SafelyHQ.com User

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