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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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Schwan's Pizza Plant, 3019 Scanlan Ave, Salina, KS 67401, United States

Total all time reports:  1
Latest report: April 19, 2020 12:00 PM
Manufacturing plant employee had tested positive for COVID-19, Schwan's Pizza Plant, 3019 Scanlan Ave, Salina, KS 67401, United States

Manufacturing plant employee had tested positive for COVID-19

April 19, 2020 12:00 PM

“Schwan’s Shared Services confirmed Tuesday that an employee at the Schwan’s Pizza manufacturing plant in Salina, KS had tested positive for COVID-19.

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

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“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

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- 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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“Interview - Maroy, Lyon France:
This is a first hand account of the coronavirus situation in Lyon France, including one member of their community that has been diagnosed, and another working in a nearby hospital.

Maroy:
I am 25 and I'm living in Lyon in the east France and it's like the third ... See Moreregion which is the most touched by the virus. And right now I'm at home since Monday the government told us to stay at home, so I'm not touched by the virus, but I know some, an old person who are touched by the virus. And I have a friend who is working in the hospital in the care units and she explained to me what the media is hiding and what's the truth behind this virus.

Safelyhq:
What area does your friend work in the hospital? And what is she seeing?

Maroy:
She's living in the South of France, Toulouse and she's in the care units. So she's working closely with the people who are in the worst situation in the hospital. So she see's a lot of cases everyday and everyday she's told me that it's worse.

Safelyhq:
Some of the materials state that it's mostly older people that are impacted, is that what she's seeing?

Maroy:
So at first in the media, they say that only old people and fragile persons who have a disease are impacted. But now this is not the truth. Now,people who are 23 years old, 25, 30 are impacted.

Safelyhq:
Have you heard anything about testing? Is it hard to get testing or is it easy to get testing?

Maroy:
Yes. One week ago I was talking with my doctor and we were talking about the virus and he told me, you know, we are talking a lot with the other doctors and I can tell you right now that we don't have in France,no testing, no tests anymore. We don't know if a person has a flu, if it's simple flu or the coronavirus and when he told me that I was really anxious because even the doctors can't diagnose now if this only a flu or if it's worse.

Safelyhq:
At the hospital, where your friend works? Is there enough room for people or are they worried about how much space they have?

Maroy:
No, unfortunately not. Now they are transferring patients to another hospital to welcome the patients who are infected by the virus. And I also heard that in some hospitals they are taking the children's room. So the services reserved for children, they are transferred to the care unit because they do not have enough room for them. They don't have enough places now.

Safelyhq:
Is there anyone that you know of or any people that you are aware ofthat directly, or through friends or family that have been diagnosed with coronavirus?

Maroy:
Yes, the cousin of my husband has been diagnosed so she's at home. She can't be at the hospital because there are too many people and they said that if she don't have struggle to breathe, she needs to stay at home. The government said that you can call emergency, only if you're struggling to breathe, if you should just have fever. Or a cough if you cough you stay at home, but really if you can't breathe you can call the emergency.

Safelyhq:
So now that you've had experience in France with coronavirus, and hearing about your husband's cousin and your friend at the hospital, what's your feeling about coronavirus and how serious it is? Are you concerned now that you have had direct impact?

Maroy:
Yes. I'm really mad get the government because they they take that too easily. They didn't do the right things at the beginning. People need to understand that this is really, really serious. And I'm pretty anxious because now yesterday I was doing shopping, so just to buy food and the all people in the grocery was afraid was wearing masks and there was nothing, people were struggling to find some pasta or something like that. And I'm really mad because we can see that a lot and a lot of people are infected by the virus. My friend who is nurse, is really afraid, she's really anxious, she's really scared to have it. She's pregnant and she needs to work even if she's pregnant. And I'm really mad against the government for that. I'm sure that if it took the good decision at the right time, they would not have a lot of cases like right now.

Safelyhq:
Is there any message that you have for people listening based on what you've learnt so far?

Maroy:
Don't take that too lightly. This is really my word, don't take that too lightly. When I see that in UK, they say that they are counting on the auto immunity of people. I just don't understand. If I have a thing to say it, don't shake hands, don't hug someone, wash your hands carefully, and just take it this really, really seriously. Because this is not a simple flu. It's bigger than that.
See Less
Reported By SafelyHQ.com User

May 20, 2020 10:00 PM

“Company name: Biota Biosciences, LLC
Brand name: Biota Biosciences
Product recalled: Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin
Reason of the recall: Unapproved new drug
FDA Recall date: May 20, 2020
Recall details: Biota Biosciences is voluntarily recalling the followi ... See Moreng lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219P / Expiration: 07/12/2021

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019P / Expiration: 10/10/2021

- Product Name: Curcumin Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219CCD / Expiration: 07/12/2021

- Product Name: Curcumin Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 0712019CCD / Expiration: 07/12/2021

- Product Name: Cannabidiol + Curcumin / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019PC / Expiration: 10/10/2021

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Cannabidiol (CBD) Complex was marketed to suppress pain and aid in the detoxification processes as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. Curcumin Complex was marketed as a potent anti-inflammatory and antioxidant that may also help improve symptoms of depression and arthritis. Cannabidiol + Curcumin was marketed as a more efficient therapeutic effect. The product was sold to certified practitioners who further administer to customers. The product is packaged in 10 mL sterile vials. Products were distributed Nationwide in the USA and one consignee in New Zealand.

Water Soluble 40mg/10m products can be identified by the labels attached.

Water Soluble 500mg/10m products can be identified by the labels attached.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 18, 2020 11:00 PM

“Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Ch ... See Moreildren's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.

Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three lots listed below:

Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)

Children's Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.

Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User