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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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Shearer's Snacks, 800 NW 4th St, Perham, MN 56573, USA

Total all time reports:  1
Latest report: April 12, 2020 12:00 PM
Shearer's Foods employee tested positive for COVID-19, Shearer's Snacks, 800 NW 4th St, Perham, MN 56573, USA

Shearer's Foods employee tested positive for COVID-19

April 12, 2020 12:00 PM

“Details: Shearer's Foods confirmed Thursday that an employee in its Perham manufacturing location has tested positive for COVID-19.
The employee has been asked to self-quarantine at home for 14 days and has not come in contact with the product so there is no food safety risk.

Report: 4/10/2020 ... See MoreSource: perhamfocus.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

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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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Reported By SafelyHQ.com User

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“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
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Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate ... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

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“Found piece of Plastic in Whole Foods Icecream. Reported the issue to Whole Foods on Jun 7th, but not sure if they are making any effort to recall the product.
UPC: 099482478209
Batch or lot code: 12-25-2020
Product name: 365 Everyday value, ... See More/chocolate#scroll" title="Product: Chocolate">Chocolate Valencia Orange Icecream See Less
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April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall ... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

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

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New Jersey, USA

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June 10, 2020 7:52 PM

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April 12, 2020 12:00 PM

“Details: Shearer's Foods confirmed Thursday that an employee in its Perham manufacturing location has tested positive for COVID-19.
The employee has been asked to self-quarantine at home for 14 days and has not come in contact with the product so there is no food safety risk.

Report: 4/10/2020 ... See MoreSource: perhamfocus.com See Less
Reported By SafelyHQ.com User