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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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Bojangles' Famous Chicken 'n Biscuits, 6820 NC-135, Mayodan, NC 27027, USA

Total all time reports:  1
Latest report: April 12, 2020 12:00 PM
A Bojangles' employee tested positive for COVID-19, Bojangles' Famous Chicken 'n Biscuits, 6820 NC-135, Mayodan, NC 27027, USA

A Bojangles' employee tested positive for COVID-19

April 12, 2020 12:00 PM

“Details: A Bojangles' employee here tested positive for COVID-19, prompting the fast food restaurant to close temporarily and send some 20 other workers home to self quarantine.

Report: 4/08/2 ... See More020
Source: greensboro.com
See Less
Reported By SafelyHQ.com User

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

Symptoms: Other
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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

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

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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

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

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

May 12, 2020 9:35 PM

“The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced the recall of approximately 3,302 pounds of meat and poultry flatbread ... See More/product/pizza#scroll" title="Product: Pizza">pizza products by Ideal Foods that were produced, packed, and distributed without the benefit of federal inspection. There have been no confirmed reports of adverse reactions related to this recall to date.

The recalled products were produced on various dates from October 2019 to April 2020 and bear establishment number “EST. 45351A” or “P-45351A” inside the USDA mark of inspection. These items were shipped to a distributor and retail locations in California.

- 13.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza CARNE ASADA”.
- 13-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza CHICKEN SPINACH ARTICHOKE”.
- 16.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza SIZZLIN JALAPEÑO”.
- 14.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza MEAT LOVERS”.

FSIS advises consumers who have purchased these products not to consume them. These products should be thrown away or returned to the place of purchase.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS See Less
Reported By SafelyHQ.com User