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Goodbye! and best wishes in your recovery

I got my first Pfizer shot yesterday. Joint pain, fatigue, soreness, Concord, NH, USA

March 18, 2021 6:37 PM

Concord, New Hampshire, United States

Symptoms: Fatigue Body Ache Joint Pain Soreness

I got my first Pfizer shot yesterday. My arm was fine till evening came and then arm became tender. The next day (today), oh boy, my joints had serious aches, I was exhausted, had to stay in bed for a while. My injected arm has serious aching. I wasn't expecting a strong reaction. I'm also recovering from Covid, six weeks now, a moderate case.

Reported By SafelyHQ.com User

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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

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Toronto, Ontario, Canada

April 22, 2021 5:57 PM

“- Never had COVID-19 before
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1st Pfizer Covid Vaccine, New York City, NY, USA

Symptoms: Nausea Soreness
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“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, Infinite Wellness of Concord, Country Club Drive Northeast, Concord, NC, USA

Infinite Wellness of Concord, Country Club Drive Northeast, Concord, NC, USA

April 7, 2021 12:00 PM

“1. Employees are concerned for their health due to the employer storing serum inside the same refrigerator used for employee food. The microwave is located next to the centrifuge. 2. The employer is not practicing social distancing.


Source: Osha.gov | Receipt Date: 2021-03-23 See Less
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Covid-19 OSHA Complaint, Helzberg Diamonds Shops Inc., 244 Sunvalley Mall, Space D116, CONCORD, CA, 94520, USA

Helzberg Diamonds Shops Inc., 244 Sunvalley Mall, Space D116, CONCORD, CA, 94520, USA

April 1, 2021 12:00 PM

“1. The employer did not ensure that effective barriers where installed to reduce the risk of transmission between patrons and employees at stations where employees show patrons the jewelry. T8 CCR 3205(c)(8)(A). 2. The employer did not ensure to reduce the number of persons in any area at a given ti... See Moreme to facilitate proper physical distancing either between other employees or customers. T8 CCR 3205(c)(6).

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Source: Osha.gov | Receipt Date: 2021-02-04
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Covid-19 OSHA Complaint, Hart Marketing LLC, 1459 Wharton Way, Unit C, CONCORD, CA, 94521, USA

Hart Marketing LLC, 1459 Wharton Way, Unit C, CONCORD, CA, 94521, USA

March 24, 2021 12:00 PM

“1. The employer did not review state and local health department guidelines in regards to operating non-essential business during the stay at home orders for Solano. T8 CCR 3205(c)(2)(F). 2. The employer did not implement an effective screening procedure to screen employees for COVID-19 symptoms. T8... See MoreCCR 3205(c)(2)(B). 3. The employer did not implement a cleaning and disinfecting procedure to disinfect high touch surfaces/objects. T8 CCR 3205(c)(8)(c). 4. The employer did not ensure to provide employees with proper hand sanitizing stations in the workplace. T8 CCR 3205(c)(8)(D). 5. The employer did not ensure employees are wearing facial coverings properly while working in the kitchen facility. T8 CCR 3205(c)(7)(A). 6. The employer did not ensure to reduce the number of persons in any area at a given time to facilitate proper physical distancing either between other employees or customers. T8 CCR 3205(c)(6). 7. The employer did not ensure to the HVAC system was maintained and operated to provide at least the quality of air required by the state building code. T8 CCR 5142(a)(1). 8. The employer did not ensure that employees do not engage in the smoking of products in an enclosed building. T8 CCR 5148(a).

Alleged Hazards: 8, Employees Exposed: 1
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Covid-19 OSHA Complaint, Lowe's Home Centers Inc. #2617, 90 Fort Eddy Rd., CONCORD, NH, 03301, USA

Lowe's Home Centers Inc. #2617, 90 Fort Eddy Rd., CONCORD, NH, 03301, USA

March 24, 2021 12:00 PM

“The employer does not have an adequate program in place to protect employees from COVID-19 and/or outbreaks. Mouse infestation where mice are in employees lockers, breakroom, in section where birdseed is stored, and at register area. Bathrooms are not being maintained and kept sanitary for employee... See Moreuse.

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Tacos El Peladito, Inc, 349 Copperfield Blvd NE, Suite K, CONCORD, NC, 28025, USA

March 24, 2021 12:00 PM

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“The employer did not give notice to employees on their exposure to a COVID-19 positive case. T8 CCR 3205(c)(3)(B)(3).

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2nd Pfizer shot, Manchester, NH, USA

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April 16, 2021 2:04 PM

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Covid Vaccine AstraZeneca, Glasgow, UK

Symptoms: Skin Rash Muscle Pain
Glasgow, UK

March 29, 2021 5:06 AM

“After I have my astrazeneca vaccine I had a bad pain in my arm for 4 days but that was not the worst part, I believe the astrazeneca triggered a bad episode of eczema as my skin was fine before the vaccine but shortly after the vaccine my skin started to flair up really badly and I’ve had to go on A... See Morentibiotics. Eczema is caused by an overactive immune response, I believe the astrazeneca triggered a strong immune response and in doing so triggered a outbreak of raw, bleeding skin which became infected and couldn’t Be treated with over the counter creams. I’ve been in severe pain with it for three weeks. I don’t know if it’s a coincidence but I didn’t have any signs of eczema before hand and I was eczema free for over a year. 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
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

April 9, 2021 6:05 PM

“Company name: NS NY Distributor Inc
Brand name: NS NY Distributor Inc
Product recalled: Premium Orgazen 7000 and Ginseng Power 5000 capsules
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 09, 2021
Recall details: Company Announcement NS NY Distributor Inc is... See Morevoluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA  analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are 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 Premium OrgaZen 7000 and Ginseng Power 5000 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 Premium OrgaZen 7000 capsules and Ginseng Power 5000 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, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.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.

- 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
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Reported By SafelyHQ.com User
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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
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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 30, 2021 10:00 AM

“Company name: Bit & Bet LLC
Brand name: Thumbs Up 7
Product recalled: Blue 69K Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 30, 2021
Recall details: Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7... See MoreBlue 69K 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 Blue 69K 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 Thumbs Up 7 Blue 69K 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, Bit & Bet has not received any reports of adverse events related to this recall. To date, Bit & Bet 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 blister foil sheets in a box labeled with UPC 6 17135 89467 3. Each box contains 10 capsules. The affected lot numbers of Thumbs Up 7 Blue 69K includes all lots. Thumbs Up 7 Blue 69K 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, e Bay 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. Bit & Bet LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and descard them.

Consumers with questions regarding this recall can contact Bit & Bet LLC by phone at (201) 208-2836 Monday to Friday from 9AM to 5PM or e-mail thumbsup7blue@gmail.com. For more information, please visit www.thumbsup7blue.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 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 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
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Reported By SafelyHQ.com User

J&J vaccine, Raleigh, NC, USA

Symptoms: Fever Itching
Raleigh, NC, USA

March 29, 2021 9:50 PM

“My wife and I wanted to get the CoV2 vaccine but had significant concerns about the messenger RNA versions.
Anyway, we got the J&J vaccine, and we are satisfied with it.

However, some things need to be stated. My wife had a 103.3-degree fever the night of her shot. I didn't feel great, but the... See Moreaftereffects took longer to present themselves. While I had a slight fever, my response presented itself as bruises that itched terribly.

We are two weeks out from the vaccine, and things are going back to normal. My wife and I had to build up our stamina from the day of the shot and now (two weeks and four days ago).

Overall, we still feel that the J&J jab was the best vaccine for us. Even though this vaccine's efficacy looks less than the others, it is quite comparable if you look at the places it was tested and when it was tested.

We would highly recommend this vaccine to all who would prefer a more conventional vaccine.
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Reported By SafelyHQ.com User

April 1, 2021 12:02 PM

“Company name: NANA Collection LLC
Brand name: PremierZen Platinum 5000, Triple SupremeZen Gold 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: April 01, 2021
Recall details: NANA Collection LLC is v... See Moreoluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared Tadalafil and Triple SupremeZen 3500 to contain undeclared Tadalafil and Sildenafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of Tadalafil and Sildenafil in PremierZen Platinum 5000 & Triple SupremeZen Gold 3500  renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Consumers with underlying medical issues who take PremierZen Platinum 5000 with Tadalafil and Triple SupremeZen Gold 3500 with undeclared Tadalafil and Sildenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.

Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NANA Collection LLC has not received any reports of adverse events related to this recall. This tainted PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 are marketed as dietary supplements for male sexual enhancement and are packaged in paper packaging with a pill blister, 1 capsule per package.  The affected PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 lots include all lot numbers to include GATCO 01671, GATCO 1805 with expiration date 12/30/2024. The product can be identified by the word ZEN stamped on the capsule along with PremierZen and Triple SurpremeZen written on the packaging.

PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. NANA Collection LLC is notifying its customers by this press announcement and via email of this recall.


Consumers that have PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 which are being recalled should discard the product. Consumers with questions regarding this recall can contact NANA Collection LLC by 201-773-8545 or nanastyle2014@gmail.com on Monday through Friday from 9am to 5pm, eastern time. 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User