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ALDI, 6524 Landover Road, Cheverly, MD, USA

Total all time reports:  1
Latest report: April 29, 2020 12:00 PM
A worker has tested positive for coronavirus, ALDI, 6524 Landover Road, Cheverly, MD, USA

A worker has tested positive for coronavirus

April 29, 2020 12:00 PM

“An Aldi employee at the Landover Rd, Cheverly location has been diagnosed with COVID-19.

Source: wusa9.com See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall ... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

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

June 23, 2020 8:01 PM

“Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling fou ... See Morer (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

No illnesses have been reported to date in connection with this problem.

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Raw chicken sandwich, Wendy's, Orlando, FL 32827, United States

Wendy's, Orlando, FL 32827, United States

June 2, 2020 9:33 PM

“just received this at your MCO airport location.. i didn’t cut into this. i was served half a raw sandwich ? See Less
Reported By SafelyHQ.com User

April 20, 2020 6:00 PM

“Company name: Braun Medical Inc
Brand name: B. Braun
Product recalled: Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container
Reason of the recall: Out-of-Specification Results for High Molecular Weight Polymers
FDA Recall date: April 20, 2020
Recall de ... See Moretails: Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels.

To date there have been no complaints or reports of adverse reactions associated with this product lot. Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections.

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:

- NDC: 0264-3145-11. Ref: 3145-11. Dose/Volume: 2 g per 50 mL. Impacted batch: H8J812. Exp. Date: 31 Jul 2020.

Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.

B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 20, 2020 11:00 PM

“Company name: Kent Nutrition Group
Brand name: Kent
Product recalled: Home Fresh Starter AMP Crumble
Reason of the recall: Elevated Salt Levels
FDA Recall date: May 20, 2020
Recall details: Company Announcement Kent Nutrition Group (KNG) of Muscatine, Iowa is voluntarily recalling 27- 25 lb.bag ... See Mores of Home Fresh Starter AMP Crumble from a single batch due to elevated salt levels, which can present illness or death to poultry. Kent Nutrition Group has ceased distribution of this lot as FDA and the company continue their investigation. Potential health risks of elevated salt levels include decreased growth rate, increased thirst, weakness, difficulty walking, difficulty breathing and death. To date, KNG has received three complaints concerning this product, which included illnesses and deaths in broilers age 12-20 weeks. This lot was manufactured at the KNG Columbus, NE plant and includes product distributed to select DO IT® Best Hardware Stores in Oregon, Washington, California, Montana and Idaho. Product subject to the recall can be identified by product code 3487 and is identified by the lot code 1020031 stamped onto the white strip sewn used to seal the package. The company is working closely with the Food and Drug Administration (FDA) to further investigate this issue and ensure the recalled products are removed from store shelves and are no longer distributed. Customers who want Information on what to do with the product and or for more information can call Kent Nutrition Group Customer Service at 1-866-647-1212 Monday through Friday from 8 AM to 5 PM Central Time. Customers who have purchased Home Fresh Starter AMP Crumbles lot #1020031 are urged to dispose of or return it to the place of purchase for a full refund.
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

June 15, 2020 10:35 PM

“My sister got a raw burger today, and was given a "free meal coupon" when she called to complain. You think she wants to go back? This was inedible. She didn't finish it, so I don't know if it would hav ... See Moree made her sick. See Less
Reported By SafelyHQ.com User

June 24, 2020 6:00 PM

“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate ... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Coop Tuna Chunks, Co-op Food - Brookfield, The Old Community Centre, Brookfield Ct, Ashford TN23 5ER, United Kingdom

Symptoms: Other
Co-op Food - Brookfield, The Old Community Centre, Brookfield Ct, Ashford TN23 5ER, United Kingdom

June 5, 2020 4:09 AM

“I had tinned tuna around 8:15pm on 4th June. I noticed the tuna appeared strange after a few normal mouthfuls. T ... See Morehe next mouthful I had my mouth was immediately stinging and it tasted slightly metallic. This put me off and I stopped eating, however, my dog had also had a small amount in her dinner. Quite soon after my stomach felt unsettled. About 30 minutes later I had heart palpitations which lasted a short while. About an hour after eating I had itchy hive like bumps appear on my stomach and lower back. My stomach and chest appeared flushed and hot. The hive bumps persisted for a few hours but I had no further symptoms. My dogs stomach also appeared unsettled soon after she ate, as her peristalsis was audible. About 3 hours after she ate the tuna she was sick and appeared quite lethargic. About 6 hours later she felt very hot to the touch and was scratching. 12 hours later she was back to normal. See Less
Reported By SafelyHQ.com User

March 17, 2020 2:35 PM

“Interview - Valorie, Pennsylvania
This is an interview with the parent of a presumptive coronavirus patient that was denied testing.

Safelyhq:
Valerie, thanks for joining us. Really appreciate it. Your situation relates to your daughter. Can you describe to us when she first felt sick and what ... See Morethe symptoms were at that time and what they've progressed to now?

Valorie:
Okay. It started on Wednesday night into Thursday. She had developed a deep cough, a dry cough, which only got louder over time as the only way I can describe it and more steady and it sounds like a pneumonia type cough. She also had a cold, a very severe cold, and then she finally didn't develop a fever until last night. So that's Thursday, Friday, Saturday, Sunday. That's how long it took to get a fever.

Safelyhq:
What was your experience in trying to get testing?

Valorie:
So today I did call her pediatrician exactly when they opened and I left an urgent message saying to please advise me what to do. My daughter now has all the symptoms of coronavirus and I don't even know if you're able to see her. And she said, no, you're right. We cannot see her. And she urged me to call a hotline. I even called urgent care, seeing if she could be seen there. They told me no, same thing call this hotline. So I called the hotline. I was on hold for approximately two hours the first time. I mean, because I estimate that because I was able to get myself and her fully ready to go, thinking that they were going to send us to the hospital wherever we needed to go to get tested. Okay. That never happened. I took a bath, had it on speaker phone, got everything ready, set us all. I mean we have a three person family and I had to hang up eventually because her pediatrician was calling me back with the response to the urgent message. The second time I was on hold, about the same amount of time I was on hold for a total of four hours today.

Safelyhq:
Is there any conditions that your daughter has that might make her higher risk or make it more urgent?

Valorie:
Yes, she has anemia and she is a very contractive person. I don't know why she gets sick every month with something in school. And that's why I looked at urging that please close the schools. Please close the schools because it just is going around. My daughter will be the one who gets it for sure.

Safelyhq:
And so do you have an idea of where she might have got it?

Valorie:
I honestly would have to say that it would be at school. Her sister didn't get it. I didn't get it. I was engaging in doctor appointments and kind of normal social activity until the end of next week because I figured sending them to school is just as bad as any of us going out into the public.

Safelyhq:
And so what are you the next steps that you plan to take given you've had a hard time getting medical care?

Valorie:
Well I plan on just calling the hotline again tomorrow. What the pediatrician did do, I guess to cover their own end of the spectrum. They sent over an urgent RX to the pharmacy for amoxicillin just in case. Just in case it is not a virus. Then if that doesn't treat it, that's how I know sooner. You know what to do. So if that doesn't treat it, and if I can't get through on the hotline, I just plan to drive to the hospital, which was designated as a location anyway through our healthcare system and go in myself and alert them ahead of time.

Safelyhq:
And what is your message to people that are concerned about coronavirus now that it's, it's something that you've seen firsthand. Do you have a message for other people?

Valorie:
A message that's kind of hard to come up with? Everybody's healthcare system is going to be different, if you don't succeed at first. There's got to be another step you can take. Be proactive. think of yourself, think of your family, and do whatever you feel is best, not what a hotline is telling you or say. And not exactly what your doctor's telling you or say. If you want to be tested, find a way.
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Reported By SafelyHQ.com User

June 5, 2020 4:00 PM

“Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
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 05, 2020
Recall details: Teva Pharmaceuticals U ... See MoreSA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). 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. Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020

- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User