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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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Best Care Nursing & Rehabilitation Center, 2159 Dogwood Ridge Rd, Wheelersburg, OH 45694, USA

Total all time reports:  1
Latest report: April 20, 2020 12:00 PM
Nursing and rehabilitation center employee has tested positive for COVID-19., Best Care Nursing & Rehabilitation Center, 2159 Dogwood Ridge Rd, Wheelersburg, OH 45694, USA

Nursing and rehabilitation center employee has tested positive for COVID-19.

April 20, 2020 12:00 PM

“An employee at Best Care Nursing and Rehabilitation Center in Wheelersburg has tested positive for COVID-19.

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

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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 ... See Morearily 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
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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.

User:
All right. I'm located in Petaling Jaya city in Selangor in ... See MoreMalaysia.

Safelyhq:
Okay, thanks. And what's the scenario in, in your case, how has coronavirus impacted, or what's the experience that you've had?

User:
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.

Safelyhq:
Do you know how testing worked for your colleague's mother, if she was able to get successfully tested and how that worked?

User:
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.

Safelyhq:
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User:
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
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“The FDA has shared best practice guidelines for restaurants, delivery services, grocery stores, and other retail food businesses that address key considerations for employee health, cleaning and sanitizing, and personal protective equipment (PPE), as well as how food can be safely handled and delive ... See Morered to the public key to keep their employees and customers safe during the COVID-19 pandemic.

The FDA guidelines address 4 specific areas:
1) *Monitor Employee Health* - Management must instruct employees to speak up about possible COVID-19 symptoms or exposure and implement workplace controls to screen and reduce possible transmission. Workplace controls can include: Pre-screening employees for high temperatures, increase disinfecting and cleaning of workspaces and equipment, wearing personal protective equipment (PPE) such as face mask and gloves, and practicing social distancing of at least 6 ft when possible.
2) *Emphasize Personal Hygiene for Employees* - When working, employees must wash their hands with soap and water for at least 20 seconds especially after using the bathroom, before eating, and after blowing your nose, coughing, or sneezing. If soap is not available, employees must use an alcohol-based sanitizer with at least 60% alcohol. Employees should also avoid touching exposed food or surfaces with their bare hands and need to always wear gloves.
3) *Follow and Enhance Food Safety Protocols* - Food establishments must follow established food safety protocols such as cooking foods to the proper temperature and separating raw and cooked ingredients. In addition to standard safety protocols, establishments need to increase safety measures to help customers maintain infection prevention by encouraging spacing in lines, discontinuing salad bars and buffets, and discouraging bringing pets into stores.
4) *Manage Food Pick-Up and Delivery* - For food pick-up, establishments need to create protocols to allow customers to maintain social distancing and maintain food safety standards. FDA recommends the creation of designated pick-up zones to allow for customers to maintain proper social distancing. For delivery, no-contact delivery and customer communication via Text and calls should be enacted.

This is not a comprehensive list and is only best practice guidelines from the FDA. If you spot issues or violations, please report at https://safelyhq.com/tag/coronavirus-covid-19

To review the in-depth guidance from the FDA please go here: 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
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Reported By SafelyHQ.com User

March 18, 2020 2:42 PM

“An employee at a Waffle House has tested positive for coronavirus, according to the restaurant. That employee works at the restaurant at 1849 Marietta Highway in Canton, Georgia and the location is temporarily closed.

"During the restaurant closure, we sanitized the restaurant thoroughly, using ... See Moremethods specifically designed to clean and disinfect," said the Waffle House Director of Public Relations Njeri Boss (...).

Waffle House said the employee last worked on March 1 and that the 12 co-workers who worked with that person were instructed to self-quarantine at their homes through Saturday, March 14.

Source: 11alive.com
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Reported By SafelyHQ.com User

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 ... See Moreconducting 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
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Reported By SafelyHQ.com User

July 2, 2020 9:00 PM

“Company name: Transliquid Technologies LLC
Brand name: Mystic Shield
Product recalled: Mystic Shield Protection Topical Solution
Reason of the recall: Undeclared methanol
FDA Recall date: July 02, 2020
Recall details: Company Announcement Transliquid Technologies LLC is voluntarily recalling al ... See Morel Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. The firm’s independent testing found the products contain undeclared methanol. Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.”

To date, Transliquid Technologies LLC has not received any reports of adverse events related to the product in question. The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in an 8.45 ounce (250 ml) blue or green labeled bottle with a white or transparent cap and bears a green or blue label identifying Mystic Shield Protection. The product was distributed between May 21, 2020-June 30, 2020 to select wholesale and retail customers in California, Louisiana, Massachusetts, and Texas.

Transliquid Technologies LLC has accounted for and prevented distribution of a substantial majority of the product at the consumer level and is arranging for its return. Transliquid Technologies LLC is notifying its distributors and customers by email and first-class U.S. Mail and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have Mystic Shield Protection hand sanitizer, which is being recalled, should stop using and return to the place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 6, 2020 3:00 PM

“Company name: ITECH 361
Brand name: All Clean
Product recalled: Hand sanitizer
Reason of the recall: Potential presence of methanol (wood alcohol).
FDA Recall date: July 06, 2020
Recall details: Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, ... See MoreMoisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning To date ITECH 361 has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers. ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products. Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase. Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at corina@itech361.com, Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to 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. Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User