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McDonald's, North Reed Avenue, Reedley, CA, USA
Total all time reports: 1
Latest report: April 17, 2020 11:57 PM
Mcchicken had a black sliver in it
April 17, 2020 11:57 PM
“I didn’t eat it but my Mcchicken had a black sliver in it and this was going to be eaten by my grandma and I went to have it replaced but they gave me the same ... felyhq.com/product/burger#scroll" title="Product: Burger">burger but took out the sliver after five people touching it too and tried to pass it off as a fresh burger and I have pictures of before and after but I don’t know how to attach pictures ”
McDonald's, Surrey, BC V3S 9A5, Canada
July 9, 2020 12:00 PM
“An employee at the Cloverdale McDonald's on Highway 10 has tested positive for COVID-19. The employee worked their last shift on July 1 from 12 p.m. to 4 p.m.
Source: langleyadvancetimes.com ”
McDonald's, 17960 56 Ave, Cloverdale, BC V3S 1C7, Canada
July 9, 2020 12:00 PM
“An employee at McDonald's on 56 Avenue in Surrey has tested positive for COVID-19. The employee last worked on July 1
Source: bc.ctvnews.ca ”
McDonald's, Mercier, QC J6R 2A3, Canada
July 8, 2020 12:00 PM
“an employee at McDonald’s restaurant located on Saint-Jean-Baptiste Boulevard in Mercier has tested positive for Covid-19.
Source: world-today-news.com ”
McDonald's, 1095 Woolridge St, Coquitlam, BC V3K 7A9, Canada
July 2, 2020 12:00 PM
“A McDonald's Employee on Woolridge Street in Metro Vancouver tested positive for COVID-19
Source: vancouverisawesome.com ”
Employee test positive for Covid-19, McDonald's, 114 S Kamehameha Hwy, Wahiawa, HI 96786, United States
McDonald's, 114 S Kamehameha Hwy, Wahiawa, HI 96786, United States
July 2, 2020 12:00 PM
“An employee at the Wahiawa McDonald's tests positive for Covid-19
Source: hawaiinewsnow.com ”
McDonald's, Camp Road, Hamburg, NY, USA
June 23, 2020 11:29 AM
“I went to your location, which is 20+ minutes away from my house, I get home and bite into a nugget, and my 10 pack McNuggets all came RAW. Never eating there EVER again. Hoping I don’t get food poison ... ing ☺️ ”
McDonald's, 31 Providence Hwy, Norwood, MA 02062, United States, McDonald's, 31 Providence Hwy, Norwood, MA 02062, United States
McDonald's, 31 Providence Hwy, Norwood, MA 02062, United States
June 22, 2020 5:43 PM
“just came to a 24 hour location and then quarter pounder is cold and raw help!!! should I be worried about food poisoning ???! This is disgusting ”
McDonald's, 1000 E Church St, Cherryville, NC 28021, USA
June 17, 2020 12:00 PM
“An employee at that the McDonald's in Cherryville has tested positive for COVID-19 on Monday June 15.
Source: wsoctv.com ”
Fast food employee worked with Covid-19 for seven days, McDonald's, 2811 N Kansas Expy, Springfield, MO 65803, United States
McDonald's, 2811 N Kansas Expy, Springfield, MO 65803, United States
June 15, 2020 12:00 PM
“A recent case worked while sick at McDonald's for seven days. The list of dates and times worked at the McDonald's on the following days:
Friday, May 29 from 5 a.m.- 9 a.m.
Saturday, May 30 from 5 a.m. - 8:20 a.m.
Tuesday, June 2 from 5 a.m. - 2 p.m.
Wednesday, June 3 from 6 a.m. - 3:30 p.m. ... Friday, June 5 from 5 a.m. - 2 p.m.
Saturday, June 6 from 5 a.m. - 2 p.m.
Tuesday, June 9 from 5 a.m. - 12:45 p.m.
Anyone who was at the location on those dates should monitor for symptoms and please report it and any other location that you visited.
Source: news-leader.com ”
McDonald's, 243 Woodlawn Rd W, Guelph, ON N1H 7L6, Canada
June 15, 2020 12:00 PM
“Today, June 11, an employee from 243 Woodlawn Road West in Guelph, ON reported testing positive for COVID-19. If you visited the restaurant recently, please report it and any other location that you visited.
Source: guelphmercury.com ”
Recent Interesting Reports
Allergic to Meat and Given a Chicken Quesadilla, Taco Bell, 2410 East Rand Road, Arlington Heights, IL, USA
Taco Bell, 2410 East Rand Road, Arlington Heights, IL, USA
June 25, 2019 10:54 PM
“I am a vegetarian and ordered food. I was shell shocked after i received chicken ... -link" href="https://safelyhq.com/product/quesadilla#scroll" title="Product: Quesadilla">quesadilla and unknowingly i took a bite of it. On checking with the manager he told sorry and said he is not responsible for his employee mistake and said he is not sure on how to comaint this to a higher level. Also he said if anything happens to me i should come back and then sue the company.i am allergic to meats please let me know how to take this. I am feeling so pukish ”
Amneal Pharmaceuticals LLC Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA
June 1, 2020 6:00 PM
“Company name: Amneal Pharmaceuticals LLC
Brand name: Amneal
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 01, 2020
Recall details: Amneal Pharmaceuticals L ... LC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels.
FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall. Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.
Risk Statement: 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 found in water and foods, including meats, dairy products, and vegetables. Metformin HCl Extended-Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.
Metformin HCl Extended-Release Tablets, USP, 500 mg
53746-178-01. 100 count bottles
53746-178-05. 500 count bottles
53746-178-10. 1000 count bottles
53746-178-90. 90 count bottles
53746-178-Bulk. Bulk Box
65162-178-09. 90 count bottles
65162-178-10. 100 count bottles
65162-178-11. 1000 count bottles
65162-178-50. 500 count bottles
Metformin HCl Extended-Release Tablets, USP, 750 mg
53746-179-01. 1000 count bottles
53746-179-Bulk. Bulk Box
65162-179-10. 100 count bottles
The affected Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers, and Repackagers.
Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of all the recalled products. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.
Check the full recall details on fda.gov
Source: FDA ”
Interview - SafelyHQ User in Malaysia - Live Account of the Coronavirus Situation, Petaling Jaya, Selangor, Malaysia
Petaling Jaya, Selangor, Malaysia
March 18, 2020 2:36 PM
“Interview - SafelyHQ User in Malaysia:
This is a first hand account of the coronavirus situation in Malaysia. The user discusses a colleague's mother being infected, tested, and treatment as well as the situation in the country.
All right. I'm located in Petaling Jaya city in Selangor in ... Malaysia.
Okay, thanks. And what's the scenario in, in your case, how has coronavirus impacted, or what's the experience that you've had?
Initially I thought it wasn't that bad because there were the only like 20 cases, so I thought with 20 cases, you actually just heal up then, it explode to about 50 or a hundred cases. And one of those cases actually affected a colleague's mother in my workplace. And so, we were all given the directive to self-quarantine immediately while the office was getting sanitized. The effect it has had, is a little bit surreal to know that it's coming very close, in terms of actually effecting one of the colleagues. But thankfully he has been tested negative so far so that's a good thing. So just after that, just last night or something, our prime minister declared a movement restriction order in that nonessentials services will be closed and things like it. So things are getting serious and we just had two deaths in the country. Two people have been killed by the virus. And that's a pretty profound and the statistics are climbing for us, like almost 700 people are affected by the virus. I do not know what is the full impact of the restriction order. How will it be enforced, whether there'll be any enforcement of the restrictive order. Some private premises have already started closing. There are closure notices everywhere and things like that. We see councils and staff that are issuing notices of which places they're closing, which places they're checking. Even my friend has a small restaurant and he's saying that it's only open for take away. So, it remains to be seen how these will really affect me and the community and things like that.
Do you know how testing worked for your colleague's mother, if she was able to get successfully tested and how that worked?
I do have an account of the experience, she checked into the hospital with some fever and they did an initial test on her. The test that she took, it takes two days to have results. So after two days, they knew that was positive and by that time it was like Tuesday or something like that, Tuesday or Wednesday. And then we got the news then I was immediately told to evacuate the office because he was in office on Monday for a few hours so they might be some contamination and things like that. So on the colleague's mother, after the test was done she was warded into the hospital, special ward and was taken care of. And so far only experiencing mild fever and things like that. And after that she was tested a second time and it was still positive. The son is negative, and so far well she still has the virus inside her. Yeah, it's already been two weeks and not this week. So, we are not sure what is going to happen.
Now that you're impacted by coronavirus, do you have any message to people, now that it's something you've experienced personally or any recommendations?
Okay. basically just stay away from large crowds. Stay within your own home if possible as much as possible. Only go out if you absolutely need to like get groceries done or get food or things like that, which is basically the aim of this movement control that we are having now. Basically that for individuals, do not travel, interstate or do not travel long distances back to your hometowns or homelands because that might cause the infection amongst other people who are older or elder, it's mostly the elderly people who get affected the most with the underlying conditions. However, one of the deaths in our country, is from a 34 year old men. Who didn't have any preexisting conditions. So that's actually quite scary. For this, I think the advice of staying away from people, and keeping checks on your health and practicing all the hygiene things, washing your hands for 20 seconds, wash up your hands and hand sanitizers and things like that ”
6 employees tested positive - Veterans Program/SSVF, American GI Forum National Veterans Outreach,, 206 San Pedro Avenue, San Antonio, TX, USA
American GI Forum National Veterans Outreach,, 206 San Pedro Avenue, San Antonio, TX, USA
April 23, 2020 8:51 AM
“At least 6 employees at this location have tested positive for COVID 19. 5 other area awaiting results. If you were at this location within the last 2 weeks, please call Metro Health to report it. ”
July 7, 2020 3:00 PM
“Company name: Mylan Institutional LLC
Brand name: Mylan
Product recalled: Daptomycin for Injection
Reason of the recall: Presence of particulate matter
FDA Recall date: July 07, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is ... conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.
Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:
- NDC #: 67457-813-50
- Material Description: Daptomycin for Injection
- Strength: 500 mg/vial
- Size: 20 mL vial
- Lot No: 7605112
- Expiry: October 2021
Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing.
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 ”
Viva Chicken Elizabeth Avenue, 1617 Elizabeth Ave, Charlotte, NC 28204, United States, Viva Chicken Elizabeth Avenue, 1617 Elizabeth Ave, Charlotte, NC 28204, United States
Viva Chicken Elizabeth Avenue, 1617 Elizabeth Ave, Charlotte, NC 28204, United States
July 7, 2020 4:35 PM
“you guys sold me undercooked chicken ”
Wendy's, 280 Larkfield Rd, East Northport, NY 11731, United States, Wendy's, 280 Larkfield Rd, East Northport, NY 11731, United States
Wendy's, 280 Larkfield Rd, East Northport, NY 11731, United States
June 15, 2020 7:54 PM
“this is what you sold to my boyfriend. Do you have anything to say for yourself? Because I’m looking at a breaded piece of raw chicken in between two buns ”
March 13, 2020 7:04 PM
“Interview - SafelyHQ user in the United States:
This is a first hand account of a user that has coronavirus Covid-19 symptoms, how he thinks he contracted it, his struggles to get tested, and what he thinks of the current situation.
When did you first feel sick- and what symptoms did ... you have at that time?
I first felt it five days ago, upon waking up. I feel like I had head pain, some sort of fever feel, my brain wasn't quite clicking as sharply as it normally does then on that first day I started having sporadic body pains around my back and my kidneys maybe around my liver area. But it was mostly the head and that really progressed through the next day where I had a throbbing headache, and this is very strange for me, as I never have headaches. Growing up I just never really had headaches, so for me to get that was kind of alarming in and of itself, and at the same time to know that there's this outbreak going on around the country with coronavirus. It was pretty scary. But, again it was hard to predict or understand, it could have been the flu could have been a cold. I wasn't sure early on those first couple days of what I had because I didn't I didn't have the symptoms that they were specifying on the CDC portal which was cough, shortness of breath and a fever. So although I felt like I had a fever I wasn't running a temperature. I didn't have a cough and I did not have a problem with breathing. In fact, I was still working out, running and had no physical debilitation, it was just more or less a roller coaster ride of pain, pain throughout my body.
What are your symptoms today, and how does it compare to the flu?
It’s a good question, I've actually never had the flu. So it's tough to compare. I would imagine that may be similar, you know, it's not terrible, but it’s not good, it’s a bad feeling, it’s constant discomfort, it does go up and down, you know, sometimes I feel better than others, but, to answer your first question I’d say the pain peaked on the second night, but not by much, it's still there. I've improved largely but I still feel bad. I don't feel the energy to do a lot of things, you know, I'm trying to do some things on my computer, but the focus isn't there. I think there's also some anxiety that comes along with the unknown of where's this thing going and what's going on but, five days in Patrick. I'm still not in good shape.
How long before you realized it might be coronavirus?
I think it was the afternoon of the third day because after that length of time, I began to worry because normally even with the flu or other ailments they tend to be a day, and a half, a couple of days, and then you start seeing progress or feeling better. I wasn't feeling any better, and I was doing the right things. I was getting sleep, I was taking vitamins, I was taking over-the-counter medications, you know, I had gone and seen the doctor. I just wasn't making any progress. That's when it hit me that wait a minute this might be coronavirus.
Can you relate it to anywhere you have recently been that you think you might have contracted it?
Yeah, so I had just come back from Europe and I think there is a direct correlation to that and the virus, and I think that's where I picked it up because the day after I got back is the day that I first started having symptoms
When did you decide to get medical attention/testing?
It was really on the third day, unfortunately my doctors office was closed that day, I went to and Emergency Walk-In Clinic and that's where they performed the Flu A, and Flu B test whether in five minutes, both of those came back negative and considering the fact that I hadn’t improved and, I had actually gone to the emergency clinic on the fourth day, so considering I had gone four straight days with these ailments and the fact that I've just come back from Europe doctors said it’s an 80% chance that I have coronavirus but, unfortunately, there's no tests available and of the tests that are available in some of the larger hospitals they are only providing those to the elderly, people who have high risk with pre-existing conditions such as diabetes high blood pressure and asthma and since I don't qualify for that, even if I went to the hospital waited hours, they would just send me back home.
So at that point, with 80% chance, is that when you started to think about self quarantine?
Yes and actually before that, so yesterday before I went to the emergency clinic, I decided to self quarantine and stay in my apartment because at that point I realized this wasn't just some sickness, this was something serious and highly likely to be coronavirus and considering the fact that that it's fairly deadly to those at risk. I definitely don't want to put anyone at risk.
What are the things the medics recommended you do. Did they have some recommendations, to limit symptoms?
Yeah, actually the doctor was very proactive, he was a very sharp guy, he seemed to understand a lot about this disease, even though they don't have the testing for it, he know that the contagious period is about 14 days and he said you are on day 5 so you need to stay home for another 10 days, but he said there's really nothing, there are no known treatments, not even over-the-counter. It's pretty much just rest, get plenty of fluids there's no medicine, nothing that they could prescribe to help.
How do you think you got it?
Well looking back. I think I got it either in an Uber, when we were in Europe last week or that I got it at a restaurant or bar that we visited, you know, one of the things going over there, there were probably about 10% of people that I saw whether at the airport or out and about wearing masks and I didn’t wear one some of my friends did that were with me. We were all vigilant about using hand sanitizers constantly, washing hands, I have always been a very clean person inherently. In fact, I've never had any real ailments in my life. I've never had the flu, never had a cold. So we thought we were pretty prepared. We weren't that worried because most of the cases were in other parts of Europe and not where we were at and I think if I had to guess looking back that it was probably an Uber because now that I've done more research, I've learned that it's not what they initially said that it's all about touching and touching your face and that's how you get it. I think it's more airborne than people realize, and they have done some studies recently that show that that the virus can actually stay afloat in the air for up to three hours. So you can imagine all the people getting in and out of cabs or Ubers, not only are they touching the same door handles sitting in the same seats, but they're also going to be breathing residual air, which can contain this virus. I think that's probably how I got it was through the air and Uber.
Were you with others, and do you know how they are doing ?
Yeah, I was with a group of other people and all but one of them is now sick. And in fact, one of them who lives in another country and is now back home just got tested today, and I think, as I mentioned earlier I'm not able to get tested because of my age and the fact that I don't have any pre-existing conditions which would put me at risk. So, you know even in a big city here in the US, they are not willing to test me so I really don't have any options directly. But I guess it's somewhat of a blessing that my friend in their country they’re easily able to get tested. Unfortunately we won't know the results for another 72 hours but at least then we'll have some peace of mind knowing that that's what this is because whatever this is, it's certainly bringing me down. It's keeping me at home and I don't feel well. So I’m looking forward to understanding if it is, what I’m pretty certain it is.
Can you describe your age range, and your health and fitness level, what kind of health you were in prior to this. ?
Yeah, I'm 37 and in really good shape, I work out frequently, in fact up until two days ago. When I started quarantining myself I was still active in the gym working out. So for me to get this, this is kind of shocking. If I can get anybody can get it, but I do know that like I said one of our friends did not get it. I think there will be people who inherently are, maybe it doesn't multiply in their bodies as fast or they're just naturally immune. We know that this is now a Pandemic virus, which means everyone hears the word novel. I didn't understand what that was until I watched a series on Netflix last night. I think it was called Pandemic, and they were talking about this very thing happening. They have these super flu’s which come around, and go and they mutate which is why every year they have different vaccines that they have to come up with, but you are able to stay ahead of those mutations with the vaccinations. This is something that humans have not experienced before this particular strand this particular type. So on the whole most people have zero defense for this. Which is why I think it takes so many days for your body to figure out what's going on. What is this? How do we fight it and to kind of fight through it? I think that’s also why the death rate is 20 times higher than the regular flu because, you know, people talk about the deaths in China most of them are elderly individuals, but they're also a elderly individuals who smoked so they've already put their lungs at risk and knowing that this virus really likes to attack the respiratory system. Yes, that's definitely a concern
Now that you are dealing with coronavirus directly, are you less worried about coronavirus or does it make you more alarmed?
Yeah, I think it's a little bit of both, I mean three weeks ago here in the United States it really wasn't much of a concern because we had a handful of cases, it was largely a problem in China, but the situation I think is going parabolic. I think the number of people that have it is vastly understated as you can see in my case, they refuse to test me, but I pretty much have it and there's probably many people like me that are either kind of hiding the issue or not sure what they have or they're in a situation where they're trying to get up in front of it. They're trying to find out more but they're being held back by the situation with our medical industry. In other countries that have far fewer cases and far fewer resources and far less money, they have unlimited capabilities to get testing out to people, drive through test windows, we're just really behind on that so to some degree I’m less alarmed personally because it's okay, I've got it now, my body is fighting through it, hopefully I get through this thing. You know, I'll have natural defenses going forward but the economic impact is scary. What is this going to mean for people that I know that are in industries where they can't work remotely long term, are companies going to go bankrupt and if the airlines are told that they have to shut down for two months, what is this going to do? There is so much fear not just health wise but to our daily lives, the NBA’s canceled, Major League Baseball's canceled the Masters PGA golf tournament is canceled, I mean this is huge, this is unprecedented, I mean even for 911 we didn't have this type of shut down even major wars, world war II, we didn't have these types of shutdowns, I mean a life continue, even though we were facing something very grave, whether it was potential additional terrorist attacks or back to WWII, potential invasion. Now, we have something as simple as a virus that is causing an unprecedented shutdown of daily life, and who knows when it's gonna get back to normal and once we get back to normal how many people have died and you know it’s people that we know, people that we care about, that we love which is so much uncertainty. So, I think on the whole I would have to say I'm even more fearful now because I don't think any of us understood how rapidly this thing was going to expand and how serious it was going to be.
What is your message to people concerned about coronavirus?
Yeah, I think if you're at risk you really need to try to stay at home as much as possible. If you're out, wear a mask, I know the mask won’t prevent it. But again, I'm pretty confident that most people are getting this through the air so it would limit the amount of particles going in your lungs. But again, if you're at risk, I think you gotta stay home as long as possible because in the event that this thing turns out to be seasonal, meaning like similar flu’s they tend to die off in warmer temperatures, we are only a couple months away so people who are at risk can do that, then need to, and then for people who aren’t at risk they need to be careful about who they're interacting with because this virus can be contagious from a person who doesn’t have symptoms or you can be contagious and the symptoms take 5 to 10 days to show up, in the meantime, you could have interacted with your grandmother your grandfather and got them sick. So I know it's a very difficult thing to ask or to say but people are going to have to think outside the box. You got to think ten steps ahead because like me, you know, I went on a trip to Europe thinking oh, well, I'm going to part of Europe that was not really infected I'm young, I'm not worried about it and that turned out to be a mistake. You know, I think you've just got to be very disciplined. If you care about people if you're concerned. You got to stay away from public gatherings. You have got to wear masks and you gotta stay out of confined area spaces as much as possible because either it's going to be you or it's going to be someone else that you know, that could get impacted by this in a bad way.
Thank you so much for sharing. Really appreciate it. We wish you all the best and getting it over this really fast.
Well, thank you very much Patrick, and I'll keep you informed as things progressed. ”
Ladue Schnucks employee tested positive for COVID-19, Schnucks Ladue, 8867 Ladue Rd, St. Louis, MO 63124, USA
Schnucks Ladue, 8867 Ladue Rd, St. Louis, MO 63124, USA
April 12, 2020 12:00 PM
An employee at the Schnucks in Ladue has tested positive for COVID-19. The employee had not been to work since April 2 and is now quarantined at home.
The store is now open to customers after the deep cleaning.
Source: ... >kmov.com ”
Nizatidine Oral Solution 15 mg/mL - recalled due to NDMA (Nitrosodimethylamine) impurity, Bridgewater, New Jersey, USA
Bridgewater, New Jersey, USA
April 15, 2020 8:00 PM
“Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is volunt ... arily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: 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. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020
The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
Check the full recall details on fda.gov
Source: FDA ”