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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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Krispy Kreme, 9950 SE 82nd Ave, Portland, OR 97086, USA

Total all time reports:  1
Latest report: November 18, 2020 12:00 PM

Covid-19 OSHA Complaint

November 18, 2020 12:00 PM

“Serious

Alleged Hazards: 1,
Source: Osha.gov | Receipt Date: 2020-06-26 See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

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December 23, 2020 10:00 PM

“Company name: Shane Erickson, Inc. DBA Innovative Marketing Consultants
Brand name: IMC
Product recalled: Wash-Free Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: December 23, 2020
Recall details: Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG:... See More2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in the table below 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 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, Shane Erickson, Inc. has not received any reports of adverse events related to the product(s) of this recall. Recalled Products:

- IMC Wash-Free Hand Sanitizer 50 ml, 1.7 oz (8 19845 00597 8). Lot: 43962. Expiration date: 45056
- IMC Wash-Free Hand Sanitizer 100 ml, 3.4 oz (8 19845 00598 5). Lot: MFG: 2020/05/10 L/N: 20200510-3. Expiration date: N/A
- IMC Wash-Free Hand Sanitizer | Wash-Free Hand Sanitizer | Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml, 10.14 oz (8 19845 00599 2). Lot: 43962. Expiration date: 45056

The product is used as a hand sanitizer for handwashing to decrease bacteria on the skin when soap and water are not available. All products are packaged in a plastic bottle. The 50 ml are in a HDPE opaque white bottle with a blue cap, the 100 ml is in a clear PET bottle with a clear cap and the 300 ml are in a clear PET bottle with a black pump. The product can be identified by checking the product size, UPC details, lot number and expiration date on the bottle containing the product. The product can also be identified by this information on the back label: Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, YUEWEIXIAOZHENGZI (2020) - 04 - No. 0023.

Some of the product has custom front labels (see examples below) the back label on the custom labels have the same identification information as previously mentioned above. The hand sanitizer was distributed Nationwide in the USA to wholesale and retail customers.

Shane Erickson, Inc. is notifying its distributors and customers by mail/email and is arranging for the return of all recalled products. Consumer, distributors, and retailers that have product, which is being recalled, should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Shane Erickson, Inc. by phone at 952.252.1254 [Call: 952.252.1254] or email sales@imcsuccess.com Monday through Friday from 8:00 am to 5:00 pm Central Time Zone.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Sunstar Americas, Inc.
Brand name: Paroex
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FDA Recall date: December 28, 2020
Recall details: Schaumburg, Illinois, Sunstar Americas, I... See Morenc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

To date, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified as shown in the images below Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies. SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers follow below:

-Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 16 fl.oz. Amber Bottles. NDC #: 052376-021-02. Product Code: 1789P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 4 fl.oz. Amber Bottles NDC #: 052376-021-04. Product Code: 1788P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022.

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. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue. 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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January 14, 2021 11:44 AM

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