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Primanti Brothers Deli Claimed
Updated: November 4, 2021 12:00 PM
1.) Employees showing signs and symptoms of COVID-19 are not required to quarantine per CDC requirements.
Alleged Hazards: 1, Employees Exposed: 52
Source: Osha.gov | Receipt Date: 2021-09-06 See Less
144
1. The employer does not communicate to sick employees that they should not return to work until they have met CDC's criteria to discontinue home isolation. The employer allowed a sick employee showing symptoms COVID-19 to return to work before the criteria to discontinue home isolation were... See More met potentially exposing coworkers to SARS-CoV-2. After returning to work, the employee tested positive for COVID-19 and the employer did not follow CDC's guidelines to notify coworkers who were close contacts to stay home and self-monitor for symptoms potentially exposing coworkers to SARS-CoV-2.
Alleged Hazards: 1, Employees Exposed: 10
Source: Osha.gov | Receipt Date: 2021-01-27 See Less
61
1. Employees only attended a one hour meeting to prepare them for the workplace changes and employees did not have time to train or learn to implement the new policies. 2. Customers come in without masks, congregate and walkaround despite signs indicating not to do so. Mask... See More wearing for customers is not enforced and greatly affect hosts and bartenders due to close proximity. 3. Additional seats are brought to the bar and social distancing is not enforced. 4. New cleaning procedures cannot be implemented because of being short staffed. 5. Sanitizer buckets aren't being changed every hour like they should. High touch surfaces are not being cleaned every hour like they're supposed to.
Source: Osha.gov | Receipt Date: 2020-06-29 See Less
484
1. A Manager was showing symptoms of COVID-19 on Friday, July 10, 2020, and was not permitted to leave the restaurant. The employer did not follow Centers for Disease Control and Prevention (CDC) guidelines for actively encouraging employees who are sick or have recently had a close... See More contact with a person with COVID-19 to stay home. The employer does not have policies that encourage sick employees to stay at home without fear of reprisal, and ensure employees are aware of these policies. Other employees that work at the restaurant and came into contact with the Manager during their regular duties potentially were exposed to SARS-CoV-2.
Source: Osha.gov | Receipt Date: 7/13/2020 See Less
39
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Amneal Vancomycin Hydrochloride for Oral Solution - recalled due to super poteny risk, USA
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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
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