Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case! Your contact information is not shown on the website.
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Use camera
Select from library
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!
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)
Visit our learn pages for more helpful information or, email us: support@safelyhq.com
Goodbye! and best wishes in your recovery
Report by
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

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)

If your report is poison related call 1-800-222-1222 for a free consultation with a live medical poisoning expert

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Side effect of Johnson and Johnson vaccine., Poland, OH, USA

April 1, 2021 7:32 PM

Poland, 44514 Ohio, United States

Symptoms: Soreness

I got the Johnson and Johnson vaccine today and my arm is sore at the injection site.  It feels like I had been punched in the arm.  I took a Tylenol and put ice on it and it feels better now.  Other than that, I feel fine.

Reported By SafelyHQ.com User

Related Reports

J&J COVID-19 Vaccine, Washington, D.C., DC, USA

Symptoms: Diarrhea Headache Chills Fatigue Sweating Muscle Pain
Washington, D.C., DC, USA

April 14, 2021 8:55 PM

“Got Johnson & Johnson COVID-19 Vaccine Sunday morning 4/11/21, in Hagerstown Maryland Outlet Mall. I am a healthy 56-yr old woman. I have never had any COVID-19 symptoms and have never been tested for COVID-19. About 12 hrs after vaccination, I felt like I had the flu, with chills, sweats, vivid dre... See Moreams, restless night, back pain, muscle aches, really bad headache, felt anxious and sad, had diarrhea, extreme fatigue, and missed one full day of work on Monday and started work late Tuesday the next day. Drank coffee and took one Ibuprofen. Drank lots of tea. Then I felt fine, appetite is back, feel back to normal but now anxious about the news about blood clots. See Less
Reported By SafelyHQ.com User

Pfizer Vaccine, Los Angeles, CA, USA

Symptoms: Soreness
Los Angeles, CA, USA

April 14, 2021 8:59 PM

“My daughter and I received our first dose of the Pfizer vaccine. We woke up tired with sore arms. The next day we were fine. See Less
Reported By SafelyHQ.com User

Pfizer vaccine causes vertigo, Stow, Ohio, USA

Symptoms: Nausea Fever Headache Dizziness
Stow, Ohio, USA

April 13, 2021 2:50 AM

“My 65 yr old godmother receivers Pfizer vaccine 4/8/21 and states she immediately had such bad vertigo she couldn’t stand. This lasted almost 24 hr. She also complained of fever, intense headache, and nausea. Admits she is hesitant about getting second dose. See Less
Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

J&J vaccine, Stow, Ohio, USA

Symptoms: Headache Fatigue
Stow, Ohio, USA

April 13, 2021 2:47 AM

“Have not had Wild covid Virus (that I know of).
J&J shot on Thursday.
Headache immediately following and almost disabling fatigue that has lasted since vaccine on 4/8/21. See Less
Reported By SafelyHQ.com User

April 12, 2021 11:43 PM

“Had the Pfizer vaccine.
After the first dosage, got a metallic taste in my mouth and felt nauseous. This took place within the first fifteen minutes.
Later, experienced a sore arm, chills, body aches, headache, fatigue and some gastric problems. Took Advil and was fine the next day.
Just had... See Moremy second dosage yesterday. Immediately had a sore arm. Later, had a headache, body aches and profound fatigue. Took a couple naps, the took Advil and went to bed for the night. Today, just a little tiredness, but feel fine.
Would definitely do over again, grateful to be vaccinated.
See Less
Reported By SafelyHQ.com User

Moderna vaccine, Canton, OH, USA

Symptoms: Fever Headache Body Ache Soreness
Canton, OH, USA

April 10, 2021 6:10 PM

“61-year-old healthy female
No history of COVID-19.
Temperature was elevated by 1-1.5 degrees in the evening.
Sore, achy, headachy upon waking the next day. That lasted for a day. Eased by Tylenol and hot shower every 4 hrs.
Fine the next day. See Less
Reported By SafelyHQ.com User

I am reporting Moderna reaction, Oxford, OH, USA

Symptoms: Nausea Fever Headache Body Ache Muscle Pain
Oxford, OH, USA

April 9, 2021 5:54 PM

“After the second shot. I had fever, nausea, headache, my body throbbed with muscles aching and fever above 100f. It took me almost 36 hrs to recover See Less
Reported By SafelyHQ.com User

Pfizer Covid-19 vaccine, Columbus, OH, USA

Symptoms: Soreness
Columbus, OH, USA

April 7, 2021 9:02 PM

“I had the first shot of the Pfizer vaccine on 2/17/21 and the second shot on 3/10/21. I had no side effects except slight injection site pain for about 24 hours after each shot. See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Whirlpool Corporation, 119 BIRDSEYE ST., CLYDE, OH, 43410, USA

Whirlpool Corporation, 119 BIRDSEYE ST., CLYDE, OH, 43410, USA

April 7, 2021 12:00 PM

“1) Employees are exposed to the hazards of COVID-19 transmission in that the employer does not enforce the company policies on wearing face coverings appropriately. Employees, including line-leaders and supervisors as well as some in upper management, routinely leave their noses uncovered and no dis... See Moreciplinary action is taken.


Source: Osha.gov | Receipt Date: 2021-03-15
See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Blue Rock Sunoco, aka Green Acres Gas Station, 8635 South River Road, BLUE ROCK, OH, 43720, USA

Blue Rock Sunoco, aka Green Acres Gas Station, 8635 South River Road, BLUE ROCK, OH, 43720, USA

April 7, 2021 12:00 PM

“The employer has not taken the appropriate steps to protect employees from SARS-C0V-2, the virus that causes COVID-19. It was alleged that the employer does not instruct workers who are infected or potentially infected to stay home and isolate or quarantine, does not isolate workers who show symptom... See Mores at work and employees do not wear masks properly.

Alleged Hazards: 1, Employees Exposed: 10
Source: Osha.gov | Receipt Date: 2021-03-15
See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

April 9, 2021 3:15 PM

“I got the j&j vac at 1:00pm its been 1 hour so far only a slight tingling on vaccination spot other than that nothing big hoping for the best See Less
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
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
Vaccine Side Effects Special summary

April 6, 2021 5:00 PM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

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

April 1, 2021 12:02 PM

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

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

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

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


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

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

Check the full recall details on fda.gov

Source: FDA
See Less
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

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 25, 2021 9:01 AM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

March 24, 2021 4:00 PM

“Company name: Alembic Pharmaceuticals, Inc.
Brand name: Alembic
Product recalled: Telmisartan Tablets, USP, 20 mg
Reason of the recall: Incorrect Product Strength on Label
FDA Recall date: March 24, 2021
Recall details: Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling on... See Moree lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Risk Statement: Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall. The product is used for the treatment of hypertension i.e. to lower blood pressure and is packaged in a bottle of 30 tablets having NDC Number 62332-087-30.

The affected lot of Telmisartan Tablets, USP, 20 mg is the lot number 1905005661 and the lot expires in March 2022. The wrong product can be identified by checking the shape and embossing details on the tablets i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped White to off-white tablets debossed with L203 on one side instead of correct product i.e. round shaped White to off-white tablets debossed with L 202 on one side. Telmisartan Tablets, USP, 20mg, Lot No. 1905005661 was distributed Nationwide in the USA to wholesalers, retailers, and pharmacies.

Alembic Pharmaceuticals Limited is notifying its distributors and retailers through letter and is arranging for return of the recalled lot. Consumers that may have Telmisartan Tablets, USP, 20 mg which is being recalled should not discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase. Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc by phone at +1 908-552-5839 (9:00 am – 5:00 pm, EDT, Monday through Friday) or email address david.cobb@alembicusa.com.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User