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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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Employee tested positive for Covid-19, Altmar-Parish-Williamstown Central School District, NY, USA

November 29, 2020 12:00 PM

New York, United States

An Altmar-Parish-Williamstown Central School District employee recently tested positive for COVID-19.

Source: cnycentral.com

Reported By SafelyHQ.com User

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“Company name: Essaar Inc.
Brand name: Soho Fresh
Product recalled: 70% Rubbing Alcohol
Reason of the recall: Contaminated with Methanol
FDA Recall date: January 04, 2021
Recall details: Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol... See Morein 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. 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 accidently 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, Essar Inc. has not received any reports of adverse events related to this recall. The product is used as an external purpose use rubbing alcohol and is packaged in 33.81 oz. clear plastic bottles with lot number 200528303 and UPC 7502268987367.

Soho Fresh was distributed nationwide to retail stores. Essaar Inc. is notifying its distributors and customers by email and mail and is arranging for the return of all recalled product to Essaar Inc. Consumers that have product which is being recalled should stop using and discard or return to place of purchase or to Essaar Inc. contacting via email or phone or mailing address mentioned above for arrangements of return. Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund or call Essaar Inc. at 201-647-7606 Monday to Friday 9am to 5pm, Eastern Standard Time. Essaar Inc. can also be reached via email at essaarinc@yahoo.com.

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. 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. FDA’s update  

Check the full recall details on fda.gov

Source: FDA
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“Company name: Sunstar Americas, Inc.
Brand name: Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
Reason of the recall: Potential contamination with Burkholderia lata
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.

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Check the full recall details on fda.gov

Source: FDA
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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 lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lot, and to return the product to Fresenius Kabi.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

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December 30, 2020 9:21 AM

“The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. As of December 30, 2020, 28 deaths and 8 illnesses in dogs that ate the recalled product have been r... See Moreeported. This is an ongoing investigation. Case counts and the scope of this recall may expand as new information becomes available.

Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets. Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.

Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness. The pet owner should remove the food and make sure no other animals have access to the recalled product. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning.

Midwest Pet Food, Inc. already recalled the following lots of Sportmix pet food products:
- Sportmix Energy Plus, 50 lb. bag. Lots: Exp 03/02/22/05/L2 | Exp 03/02/22/05/L3 | Exp 03/03/22/05/L2
- Sportmix Energy Plus, 44 lb. bag. Lot: Exp 03/02/22/05/L3
- Sportmix Premium High Energy, 50 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Premium High Energy, 44 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 31 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 15 lb. bag. Lots: Exp 03/03/22/05/L2 | Exp 03/03/22/05/L3

Check the full outbreak announcement on fda.gov

Source: FDA
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December 30, 2020 10:00 PM

“Company name: Sportmix
Brand name: Sportmix
Product recalled: Dog and Cat Food
Reason of the recall: Elevated levels of aflatoxin
FDA Recall date: December 30, 2020
Recall details: Midwestern Pet Foods, Inc., of Evansville, IN is issuing a voluntary recall of the below-listed dog and cat food p... See Moreroducts due to tests indicating levels of Aflatoxin that exceed acceptable limits. Products were distributed nationally to online distributors and retail stores. Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.

There have been reports of illnesses and deaths in dogs associated with the below listed lots of Sportmix High Energy. No cat or human illnesses have been reported. If your pet shows signs of aflatoxin poisoning including sluggishness, loss of appetite, vomiting jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea, contact a veterinarian immediately. Provide a full diet history to your veterinarian. It may be helpful to take a picture of the pet food label, including the lot number. Lot code information may be found on the back of the bag and will appear in a three-line code, with the top line in the format “EXP 03/03/22/05/L#/B###/HH:MM” as follows (see below in pictures section).

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products. Retailers are encouraged to contact consumers who have purchased the recalled products if you have the means to do so (frequent buyer cards, etc.).

Pet parents: do not feed the recalled products to your pets or any other animals. Destroy the products in a way that children, pets, and wildlife cannot access them. Wash and sanitize pet food bowls, cups, and storage containers. Contact Midwestern Pet Foods Consumer Affairs at 800-474-4163, ext. 455 from 7AM to 4PM Central Time, Monday through Friday, or by email at info@midwesternpetfoods.com for additional information. This is a voluntary recall conducted in cooperation with the U.S. Food and Drug Administration.

Recalled lot codes are as follows:

- 50# Sportmix Energy Plus Lots Exp 03/02/22/05/L2, 03/02/22/05/L3, 03/03/22/05/L2
- 44# Sportmix Energy Plus Lots 03/02/22/05/L3
- 50# Sportmix Premium High Energy Lots 03/03/22/05/L3
- 44# Sportmix Premium High Energy Lots 03/03/22/05/L3
- 31# Sportmix Original Cat Lots 03/03/22/05/L3
- 15# Sportmix Original Cat Lots 03/03/22/05/L2, 03/03/22/05/L3

Products may be identified as follows (see pictures below).

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

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