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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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Goodbye! and best wishes in your recovery

Rancho Jubilee, Sunrise Mall, Massapequa, NY, USA

Total all time reports:  1
Latest report: March 10, 2020 8:26 PM
Food poisoning, Rancho Jubilee, Sunrise Mall, Massapequa, NY, USA

Food poisoning

Symptoms: Diarrhea

March 10, 2020 8:26 PM

“I ordered two steak lunch specials from this restaurant with my husband. The food was delicious but shortly after eating my stomach felt uneasy and I had diarrhea for the rest of the night. My husband als ... See Moreo experienced similar symptoms. I hoping this was a one time thing but I’m afraid to give this place another chance. See Less
Reported By SafelyHQ.com User

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“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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April 20, 2020 4:00 PM

“Company name: Fresenius Kabi USA, LLC
Brand name: Fresenius Kabi
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Reason of the recall: Presence of Particulate Matter
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Recall details: Freseni ... See Moreus Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen, and polyamides.

Particulate matter was found in eight reserve sample vials. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

- Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial. NDC: 63323-162-01. Product code: 160201. (Check the recall notice for specific batch numbers)
- Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial. NDC: 63323-162-02. Product code: 160202. (Check the recall notice for specific batch numbers)

Check the full recalled product list and details on fda.gov

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June 18, 2020 11:00 PM

“Company name: GSK Consumer Healthcare
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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.

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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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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

May 27, 2020 9:34 AM

“I contacted the manager at your store because my sister consumed an undercooked burger last night and is now very sick. He said that there was no way she can get sick from ... See Mores://safelyhq.com/product/beef#scroll" title="Product: Beef">beef even though a quick google search says otherwise. I’m very disappointed. See Less
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April 12, 2020 12:00 PM

“Details: McPherson County says the employee was not showing symptoms while on the clock, but started to feel sick and left work for the day.

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Rep ... See Moreort: 4/10/2020
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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