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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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Chick-fil-A, 653 Atlanta Rd, Cumming, GA 30040, United States

Total all time reports:  1
Latest report: April 30, 2020 12:00 PM
Fast food worker test positive for COVID-19, Chick-fil-A, 653 Atlanta Rd, Cumming, GA 30040, United States

Fast food worker test positive for COVID-19

April 30, 2020 12:00 PM

“An employee at the Chick-fil-A at Lanier Crossing shopping center has tested positive for COVID-19 a week ago.

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

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Recent Interesting Reports

May 15, 2020 11:00 AM

“Company name: Summitt Labs
Brand name: KORE ORGANIC
Product recalled: Watermelon CBD oil tincture
Reason of the recall: Contains lead
FDA Recall date: May 15, 2020
Recall details: Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle ... See More, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement. Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.

The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Batch#730 Lot#K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs. Summitt Labs is notifying its distributors and customers by email, phone, and personal visits to ensure the return of all recalled product.

Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall.

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.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 8, 2020 12:00 PM

“Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
Reason of the recall: N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: July 08, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily ... See Morerecalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to 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 and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC’s are included in the table below:

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-338-01 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-339-09 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-336-07 / Distribution Dates: 11/05/2018 - 05/22/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-337-07 / Distribution Dates: 11/05/2018 - 05/22/2020

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC’s.

Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. 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

July 13, 2020 4:00 PM

“Company name: 4e Brands North America
Brand name: Blumen
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 13, 2020
Recall details: Company Announcement San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of H ... See Moreand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). 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, 4e Brands North America has not received reports of adverse events related to this recall. Recalled Products These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected Hand Sanitizers are packaged in clear plastic bottles. The recalled products are as follows (a full listing of lot numbers in numerical order is included below the chart):
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

August 5, 2020 9:01 PM

“Company name: Ferring Pharmaceuticals US
Brand name: Ferring, Amring, CSL Behring
Product recalled: DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL
Reason of the recall: Superpotency
FDA Recall date: August 05, 2020
Recall details: ... See MoreFerring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing. The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death.

To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed. DDAVP® Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Desmopressin Acetate Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Stimate® Nasal Spray is indicated for the treatment of patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%.

Stimate® Nasal Spray is indicated for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Ferring US is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. You can see the affected product name, including the batch numbers and expiration dates, in the link below.

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053. 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

BLM Protest, Plymouth, MI 48170, USA

Plymouth, MI 48170, USA

June 3, 2020 6:46 PM

“~10,000 people meet up in DOWNTOWN PLYMOUTH, Michigan at the fountain, park, marched the streets, and then city hall/police/fire Dept. started at 2pm...still happening at .7pm. Seems peaceful so far See Less
Reported By SafelyHQ.com User

July 21, 2020 11:53 AM

“this is RAW CHICKEN. I opened this up and took a bite without realizing it was raw till I smelt it. 🤮🤢 I am so disappointed ☹️ See Less
Reported By SafelyHQ.com User

July 6, 2020 11:30 PM

“Company name: J. M. Smucker Company
Brand name: Natural Balance
Product recalled: Ultra Premium Chicken & Liver Paté Formula
Reason of the recall: Due to elevated levels of choline chloride
FDA R ... See Moreecall date: July 03, 2020
Recall details: The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride. Ingesting impacted product may cause nausea with excessive salivation, constricted pupils and poor vision, diarrhea or vomiting to more severe symptoms including difficulty walking, muscle shaking, tremors, irregular heartbeat, difficulty breathing, possible cardiac or respiratory failure and, in extreme situations, death. Pet parents are encouraged to contact their cat’s veterinarian immediately if their cat is displaying any of these symptoms.

If pet parents have any product matching the following description in their possession, they should stop feeding it to their cats and dispose of the product. This information can be found on the bottom of each can.

- Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food (5.5 oz). UPC: 2363353227. Lot code: 9217803. Best by: 08 04 2021

These products are most commonly sold in pet specialty retailers and online throughout the United States and Canada. No other Natural Balance® products are impacted by this recall.

The Company has received reports of adverse reactions. Pet parents that have questions or would like to report adverse reactions should call 888-569-6828, Monday through Friday, 8 a.m. – 5 p.m. ET or email anytime at info@naturalbalanceinc.com.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 12, 2020 12:44 PM

“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 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 ... See MoreLC 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
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Reported By SafelyHQ.com User

April 3, 2020 2:00 PM

“Company name: IcelandicPlus LLC
Brand name: Icelandic+
Product recalled: Whole Capelin Fish Pet Treats
Reason of the recall: Potential for Clostridium botulinum
FDA Recall date: March 23, 2020
Recall d ... See Moreetails: Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5 inches have been linked to outbreaks of botulism poisoning in humans between 1981 and 1987 and again in 1991. Since some IcelandicPlus Capelins are larger than 5 inches there is a possible health risk. To date there have been no reported illnesses of dogs, cats, or persons in connection with Capelin. Nor has there been any positive test results for Clostridium botulinum from any IcelandicPlus Capelin, but because of the potential risk, and despite no known illnesses in connection with our products, we have decided in co-operation with the FDA, to announce this product recall. Clostridium botulinum toxin can cause severe clinical signs including death in both animals consuming the pet treat and people handling the pet treat or coming in contact with contact areas that have been exposed to the product. Common symptoms may include dizziness, blurred or double vision, trouble with speaking or swallowing, difficulty breathing, muscle weakness, abdominal distension, and constipation. Consider that several of the listed symptoms, such as double vision, cannot be easily assessed in animals or conveyed by an animal. Pets or persons experiencing these symptoms should seek immediate medical attention. The Capelin product was shipped to distributors in the United States with the intent to be sold to Retailers who in turn sell to Consumers. This product would be found in Independent Pet Specialty Stores within all States in the United States. The product comes in a clear plastic package or tube, and marked Icelandic+ Capelin WHOLE FISH, PURE FISH TREATS FOR DOGS, or PURE FISH TREATS FOR CATS UPC CODES, 8 5485400775 9; 8 5485400711 7; and 8 5485400757 5 are packaged in a 2.5 ounce tube or a 1.5 or 2.5 ounce bag (lot numbers 02/2020 to 02/2022)IcelandicPlus is family owned and run by pet parents who take the safety and wellbeing of its consumers and clients with the utmost importance, as such we are conducting this voluntarily recall to further protect our customers. Additionally, we are changing our Capelin supplier to ensure that the fish in our product are consistently less than 5 inches, or if larger, they will be completely eviscerated. Distributors, Retailers and Consumers who have purchased IcelandicPlus’s Capelin can return it to the location where it was purchased for a refund.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User