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

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Enoxaparin Sodium Injection, USP - recalled due incorrect dosage listed, USA

February 3, 2021 1:00 PM

United States

Company name: Apotex Corp
Brand name: Apotex Corp.
Product recalled: Enoxaparin Sodium Injection, USP
Reason of the recall: Packaging error resulting in incorrect dosage listed
FDA Recall date: February 03, 2021
Recall details: Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.

Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a l00 mg/mL concentration, patients could receive 3.75 mg of Enoxaparin, instead of 3 mg of Enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, patients would receive 2 mg of Enoxaparin rather than 2.5 mg of Enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.

Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.

The affected Enoxaparin Sodium Injection, USP can be identified by NDC numbers stated on carton and label of the product.

Product: Enoxaparin Sodium Injection, USP
Batch #: CS008
Strength: 100 mg/mL
Syringe Barrel Measurement Markings: 100 mg/mL
Pack Size: 10 x 1mL Single Dose Syringes
NDC NumberOn Carton: 60505-0795-4
NDC Number On label: 60505-0795-1
UPC Code on Carton: 360505079544
UPC Code on label: (01)10360505079510

Product: Enoxaparin Sodium Injection, USP
Batch # : CT003
Strength: 120 mg/0.8mL
Syringe Barrel Measurement Markings: 150 mg/ mL
Pack Size: 10 x 0.8 mL Single Dose Syringes
NDC NumberOn Carton: 60505-0796-4
NDC Number On label: 60505-0796-0
UPC Code on Carton: 360505079643
UPC Code on label: (01)10360505079602

The two (2) affected batches of Enoxaparin Sodium Injection, USP were distributed by Apotex nationwide in the USA to Wholesalers and Warehousing Chains. Apotex Corp. is currently notifying its affected direct account Wholesalers and Warehousing Chains, via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
United States

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January 25, 2021 7:00 PM

“Company name: Nostrum Laboratories, Inc.
Brand name: Nostrum Laboratories, Inc.
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
FDA Recall date: January 25, 2021
Recall details: K... See Moreansas City, Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide in the USA to wholesalers who further distributed to pharmacies and patients.

- Product Description: Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)
- NDC: 29033-056-01
- Lot Number: MET200601
- Expiry Dates: 07/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

January 27, 2021 9:01 PM

“Company name: Meitheal Pharmaceuticals, Inc.
Brand name: Meitheal Pharmaceuticals, Inc.
Product recalled: Cisatracurium Besylate Injection, USP 10mg per 5mL
Reason of the recall: Mislabeling
FDA Recall date: January 27, 2021
Recall details: Meitheal Pharmaceuticals, Inc. (“Meitheal”), annou... See Morenced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL. 

To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot. There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia and cardiac/brain ischemia.  If this is not quickly diagnosed and treated, severe illness or death can occur. 

There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes. Cisatracurium Besylate Injection is used as a nondepolarizing neuromuscular blocker. 

The affected Cisatracurium Besylate Injection lot being recalled is C11507A, EXP. October 2021.  The product can be identified as a 5mL vial stoppered with a rubber stopper and sealed with aluminum seal having an Aqua color flip-off seal.  Meitheal commenced shipping the product to customers on August 19, 2020 which was distributed to wholesalers nationwide in the USA.

- Cisatracurium Besylate Injection, USP 10mg per 5mL. Lot Number: C11507A*. Expiration Date: October 2021*. NDC Number: 71288-712-06 (unit of sale) |71288-712-05 (unit of use). Distribution Dates: August 19, 2020 – January 04, 2021.

*Note: Mis-labeled product will have this same Lot Number of C11507A and Expiration Date of October 2021 but will be labeled on the vial as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL, NDC 71288-808-77 (unit of use).

Meitheal has notified its distributors and customers in writing to arrange for return of all recalled product. Customers who have purchased the product should not open the carton or use its contents and should immediately quarantine and return the recalled lot of product. Customers who may have further distributed this product should promptly identify their customers and notify them at once of this product recall.

Consumers with questions regarding this recall can contact Meitheal’s Customer Service weekdays 8:00AM to 6:00PM CST at 844-824-8426. 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, as follows.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

2nd. Pfizer COVID injection., Hesperia, CA, USA

Symptoms: Fever Headache Chills Fatigue Body Ache
Hesperia, CA, USA

March 3, 2021 7:04 PM

“I was given my second Pfizer vaccine 3/1/2021. The injection itself didnt hurt, however, that night I started not feeling well, I had the chills, kept waking up through the night, had a headache, a fever, my body ached, was tired and the injection site was tender. Still glad I got it, I just took it... See Moreeasy and slept throughout the day. See Less
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Covid-19 Vaccine Experience Notifications

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Reported By SafelyHQ.com User

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Symptoms: Cramps Headache Chills Soreness
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March 3, 2021 4:58 PM

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Mild left sided chest heaviness, right leg cramps
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5:00 pm increasing left arm soreness/discomfort
Chills
9:00 pm Naus... See Moreea, dry heaves, moderate left arm pain, difficulty moving arm, could not put pressure on left arm
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Nausea, left arm pain
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March 3, 2021 4:36 PM

“Hello,

My older brother is going through a bipolar/psychotic break after multiple uses of methamphetamine and they live in Midvale, My sister in law called the police to try to have him picked up by EMS and have him blue sheeted due to him being suicidal and having delusions and needing severe h... See Moreelp. My older sister has been an MA in the medical field for over 30 years and I have been an office manager in healthcare for over 18 years and have both had many patients bule sheeted. The 2 officers (one extra large bulked up white guy and a little smaller but still muscle head mexican guy) came out to her house at Remington Apartments the morning of 3/3/2021. They basically told her that there is nothing at all they can do; they cannot blue sheet him due to being suicidal, they treated my sister in law like she was a piece of trash by trying to get him help. Told her it is not her place to try to get him committed and she has no right that he is a grown man and can do what he wants to. She told them he is sick and he really needs help it's been days that he has been threatening suicide and that she really needs them to help my brother. They did not take any names, they did not write any notes down, they did not get any info at all or want to speak to my brother my sister in law had recorded video of him twitching and having major issues. They did not even want to see the videos at all. In this day and age I cannot believe that she would be treated this way by police officers. Are you kidding me, how is there 2 officers like this on an actual police force that seriously did not do a damned thing for a suicidal man. It seems they were sexist and did not want to do extra paperwork or have to take him in. They said they can ask my brother if he wants to go to the hospital and if he wants to go they can take him, my sister in law said that is not going to work because he will not agree to go even though he is super suicidal and seeing things. They said then there is nothing we can do for you and told her that she had wasted their time and they are very busy. They did not give their names, they did not give her a card. They did not want to be known since they did not do their job at all. I want this investigated immediately and these two officers investigated and put through MUCH MORE TRAINING with drug abuse and mental disorders. My father was a police officer for over 30 years in Utah and never would have brushed anything under the rug like this. See Less
Reported By SafelyHQ.com User

March 3, 2021 4:00 PM

“Company name: Bravo Packing, Inc.
Brand name: Bravo Packing, Inc.
Product recalled: Ground Beef and Performance Dog, frozen raw pet food
Reason of the recall: Potential for Salmonella and Listeria monocytogenes
FDA Recall date: March 03, 2021
Recall details: Company Announcement Bravo Packing,... See MoreInc. of Carneys Point, NJ is recalling all Ground Beef and Performance Dog, a frozen raw pet food because it has the potential to be contaminated with Salmonella and Listeria monocytogenes. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.  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, server headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women. 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 (an infection of the heart muscle), arthritis, muscle pain, eye irritation and urinary tract symptoms. People who have these symptoms after having contact with this product or an animal that has eaten 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 decreased appetite, fever and abdominal pain. Pets exposed to contaminated food can be infected without showing symptoms. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. Infected animals 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 in the household. No human or animal illnesses have been reported to date. Bravo Packing, Inc. is voluntarily recalling the products after samples of Performance Dog and a sample of Ground Beef were collected during an FDA inspection, tested positive for Salmonella and Listeria monocytogenes. Performance Dog generally works with the distributor located in Brooklyn, New York, that fills orders to brick-and-mortar retail stores or to consumers directly nationwide. Performance Dog and Ground Beef both come frozen in 2-pound and 5-pound plastic sleeves. If you have an Ground Beef or Performance Dog, please throw it away. Consumers with questions should contact Bravo Packing, Inc. at 856-299-1044 (Monday – Friday, 9:00AM-2:00PM, EST).
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

March 3, 2021 12:39 PM

“I was trying to buy the hot GTA powered wood cutter. I received a piece of f****** chain and two ropes. That's not what I was ordering it was the song for 2999. Plus shipping. Try to email him the answer back I got was you got what you paid for we can give you 3% back. Ask for a full refund they tol... See Mored me pretty much go jump off a bridge. Apparently I am not the only one this company is taking advantage of. I would like the saw, are the saw and a full refund for the aggravation the Hassel and a headaches that we have to go through for a f****** piece of chain on a rope See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

March 3, 2021 4:00 PM

“Company name: Bravo Packing, Inc.
Brand name: Bravo Packing, Inc.
Product recalled: Ground Beef and Performance Dog, frozen raw pet food
Reason of the recall: Potential for Salmonella and Listeria monocytogenes
FDA Recall date: March 03, 2021
Recall details: Company Announcement Bravo Packing,... See MoreInc. of Carneys Point, NJ is recalling all Ground Beef and Performance Dog, a frozen raw pet food because it has the potential to be contaminated with Salmonella and Listeria monocytogenes. Salmonella can cause illness in animals eating the products, as well as people who handle contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products, infected animals or any surfaces exposed to these products.  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, server headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women. 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 (an infection of the heart muscle), arthritis, muscle pain, eye irritation and urinary tract symptoms. People who have these symptoms after having contact with this product or an animal that has eaten 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 decreased appetite, fever and abdominal pain. Pets exposed to contaminated food can be infected without showing symptoms. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. Infected animals 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 in the household. No human or animal illnesses have been reported to date. Bravo Packing, Inc. is voluntarily recalling the products after samples of Performance Dog and a sample of Ground Beef were collected during an FDA inspection, tested positive for Salmonella and Listeria monocytogenes. Performance Dog generally works with the distributor located in Brooklyn, New York, that fills orders to brick-and-mortar retail stores or to consumers directly nationwide. Performance Dog and Ground Beef both come frozen in 2-pound and 5-pound plastic sleeves. If you have an Ground Beef or Performance Dog, please throw it away. Consumers with questions should contact Bravo Packing, Inc. at 856-299-1044 (Monday – Friday, 9:00AM-2:00PM, EST).
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

February 22, 2021 11:20 PM

“I order the 2020 GTA-26 Battery powered wood cutter which they advertise at a price of $29.99. What arrived in the mail was a chain with two cloth handle, which I didn't order. They refuse to refund me or give me a return address. This is what i got in response to my request for a refund.

Pony... See MoreGreen (shenlantiaodong)
2021年2月22日 GMT+817:59
Dear customer,
Sorry to hear that you did not satisfy with the item you received.
If you would like to get the chainsaw, we may offer a discount for you to get the one you actually need.
We can make an exception for you with a surcharge $60, and you will get the chainsaw which costs $89.99. It's equivalent to you buying the chain for free. The chain you received before can be used as a simple tool as a free gift from us."

They are a complete scam
See Less
Reported By SafelyHQ.com User

Casher I’s feeling low fever, Santa Clara, CA, USA

Symptoms: Fever
Santa Clara, CA, USA

February 15, 2021 4:47 PM

“The cashier is felling sick. Every one got flu in this restaurant. This place infected with COVID 19
I got full sick. All employees are sick and needed fully attention See Less
Reported By SafelyHQ.com User
Covid-19 Vaccine Experience Notifications

2nd Pfizer vaccine, Seattle, WA, USA

Symptoms: Soreness
Seattle, WA, USA

February 21, 2021 9:27 AM

“I received the 2nd covid 19 vaccine shot from Pfizer at the Amazon site February 20th at 1:00 p.m..
I have a mildly sore right shoulder and no other symptoms. See Less
Reported By SafelyHQ.com User

February 6, 2021 5:43 PM

“I have read the other reports and totally agree this is a scam. I thought I purchased the Stihl battery cutter shown with a hand saw in the bubble. It said $29.99 so that's what I sent. The orange handled saw arrived but not the cutter. I emailed the company and they said that was what I bought. I h... See Moread to click the cutter box it showed $89.99. I really liked what was advertised so I paid it. (The hand saw definitely wasn't worth $29.99 and I thought it was a gift for getting the cutter) When the cutter arrived, it was a cheap black handsaw. Came in a cardboard box not a nice carrying case. It had a small slip on guard but not the guard and shield as advertised. There was no chain saw oil. They both had charger base and battery. I emailed them back saying this was fraud. Jennifer from the company emailed back and said she was sorry about my being disappointed. I was not to send the product back. I was to send a picture of what I got, tracking number and SKU from box. I took these pictures and sent a picture of what I was promised. There was no SKU # on box. She emailed me back and said I should not return it because it could get lost going to Hong Kong and without the product there would not be a refund. She said it probably wouldn't pass customs. I should give it as a gift and person will really like it! I wrote to the Better Business Bureau and hope to find out next step. Her comments make me fearful to return. See Less
Reported By SafelyHQ.com User

February 28, 2021 4:02 PM

“Order was sent but just a chain. This is misleading to alot of people who they are ripping off. See Less
Reported By SafelyHQ.com User

February 17, 2021 6:09 PM

“A scam regarding a small knock-off chain saw that is the center of a scam by Blackcass of Houston, TX or LA, CA or probably China somewhere. We ordered a Blackcass 2020 Hot selling GTA 26 Battery-Powered Wood Cutter X 1 in December 2020. We did received, via USPS, a 25" long segment of chain saw l... See Moreinks with Orange handles on each end, so it is NOT Battery-Operated. One of the photos in the Blackcass ad that are associated with this SCAM are EXACTLY the same photo used by the very legitimate Stihl company model GTA-26...only the word, "Stihl" is omitted on the Blackcass ad's photo. So, consumers and the real manufacturer are BOTH being scammed. See Less
Reported By SafelyHQ.com User

February 21, 2021 7:00 PM

“I ordered a battery operated mini chainsaw. They sent me a chain with a strap on each end. After many emails they told me that I did order it. No, I didn’t. 5 shoulders, I wouldn’t have. I looked them up and that is when I started finding the reports. See Less
Reported By SafelyHQ.com User

February 16, 2021 11:55 PM

“The FSA announced the recall of Boots Multivitamins supplements by Boots because they have been incorrectly packed with multivitamins containing iron. This resulted in vitamin K not being present within the supplement and iron incorrectly added to the supplements instead. Iron has not been mentioned... See Moreon the label. This means the product is a possible health risk to individuals who may also be consuming iron supplements in addition to these multivitamins.

FSA advises consumers to stop taking the multivitamin supplements. Instead, return it to the Boots store from where it was bought for a full refund. This recall affects multivitamins sold between 12 and 19 January 2021 only.

- Boots Multivitamins (180 tablets). Item code: 80 57 311. Batch code: 1805 and 1806. Best before: end of November 2022.

This product does not contain vitamin K but does contain iron. Excess supplemental iron can result in gastrointestinal effects such as pain, discomfort, constipation or nausea and vomiting.

Check the full recall details on the FSA website food.gov.uk
See Less
Reported By SafelyHQ.com User

February 11, 2021 5:22 PM

“Got my second Moderna Covid-19 vaccine shot, no side effects this time. A little tired and thirsty but so far so good. See Less
Reported By SafelyHQ.com User