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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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Blanca, Colorado, United States

Updated: January 21, 2021 12:00 PM

January 21, 2021 12:00 PM

“3 individuals at Sierra Grande School in Costilla county tested positive for Covid-19. The outbreak began on 1/18/21

Source: colorado.gov See Less
Reported By SafelyHQ.com User

December 17, 2020 12:00 PM

“3 individuals at Blanca Potato Factory in Costilla county tested positive for Covid-19. The outbreak began on 12/8/20

Source: colorado.gov See Less
Reported By SafelyHQ.com User

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January 1, 2021 9:01 PM

“Company name: Precision Dose Inc.
Brand name: GUM Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: December 31, 2020
Recall details: Company Announcement Precision Dose,... See MoreInc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata.

From information provided by the manufacturer, Sunstar Americas, Inc., 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 pneumonia and bacteremia.

To date, no adverse events have been reported to Precision Dose, Inc. related to this recall. 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 the product impacted is:

- Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62
- Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers. Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com. Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product. Affected products and lot numbers follow below: AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Check the full recall details on fda.gov

Source: FDA
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Mount Pleasant, SC, USA

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January 8, 2021 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketoro... See Morelac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

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

Source: FDA
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