114 Fisher Avenue, Ossian, Iowa, United States

Updated:

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December 7, 2020 Health: Employees are exposed to the COVID-19 pandemic. 1. Employees are not provided or updated with the current hazardous conditions in the workplace. Employees are not notified of COVID-19 infections. Employees work with COVID-19 symptoms or positive with COVID-19. 2. Some staff-members wear cloth … See More
masks and not medical masks. 3. Employees and residents with COVID-19 are not being separated from others who are presumed healthy. 4. The same PPE is used for all residents that are negative or positive of COVID-19. Employees are being forced to reuse and/or share disposable PPE gowns. Employees are denied access to their own PPE. Employees are denied new PPE when current ones are soiled. PPE is not properly stored ('bunny suits', face-masks, & face-shields) on a small rack, in an eating area. 5. Rooms are not being cleaned, sanitized, or disinfected. Many resident's rooms did not contain trash cans or bins by the exit doors to ensure proper disposal of PPE or laundry. Each resident room has gowns hanging on the outside of the door. Employee with symptoms or that tested positive for COVID-19 are still working and using these gowns. These same gowns are shared between all employees, requesting to have your own or new PPE is continually denied. 6. Aerosol disinfectant spray cans are throughout the facility and are required to use on one's entire body and surrounding area. 7. Employees being screened and deemed healthy to work shift are forced to reuse and wear PPE gowns that other worker's with covid-19 have been wearing. Facility was unable to provide information about when gowns have last been changed with new. Facility informed employees of never being able to get new PPE, including gowns, 'bunny suit', mask,' & face-shield. 8. Facility denied employees the ability to have fresh air, due to refusing to open windows, continually spraying chemicals throughout the building, and not allowing any employees out of the building during entire shifts. 9. 21 out of 28 residents in the long term care unit tested positive for COVID-19. Employees are exposed due to other staff-members working with COVID-19, the improper use of sharing PPE between staff, and reusing PPE for an extensive period of time. Location: Ossian Senior Hospice Long Term Care Unit south, east, and west halls.


Source: Osha.gov | Receipt Date: 2020-12-07
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#coronaviruscovid19 #osha #114fisheravenue #ossian #iowa #us

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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can … See More
result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: www.fda.gov
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