A
1. The employer failed to develop and implement a process for screening employees for and responding to employees with COVID-19 symptoms. The employer only screens occasionally, but not on a daily basis. Title 8 CCR §3205(c)(2)(B) 2. The employer failed to provide face coverings. The employer tells … See More
employees that if they don't have a facemask, they should go home' Title 8 CCR §3205(c)(6)(B) 3. The employer failed to review applicable orders and guidance from the State of California and the local health department related to COVID-19 hazards and prevention. Several employees are not following the most recent Alameda County orders that require all people, regardless of vaccination status, to wear face coverings indoors. The employees on the late shift will constantly wear their facemasks below their nose. Title 8 CCR §3205(c)(2)(F) 4. The employer failed to give written notice, within one business day, that people at the worksite may have been exposed to COVID-19. Written notice may include, but is not limited to, personal service, email, or text message if it can reasonably be anticipated to be received by the employee within one business day of sending. The notice shall include the disinfection plan required by Labor Code section 6409.6(a)(4). There have been at least 2 COVID-19 cases present in the workplace and all employees were not notified. The employer didn't notify any close contacts of cases that resulted in mid March 2021 and late March/Early April of 2021. Title 8 CCR §3205(c)(3)(B)(3) 5. The employer failed to provide effective training and instruction to employees that includes the following: information regarding COVID-19-related benefits to which the employee may be entitled under applicable federal, state, or local laws. This includes any benefits available under legally mandated sick and vaccination leave, if applicable, workers' compensation law, local governmental requirements, the employer's own leave policies, leave guaranteed by contract, and this section. As well as training in the importance of frequent hand washing with soap and water for at least 20 seconds and using hand sanitizer when employees do not have immediate access to a sink or hand washing facility. Additionally, training in public health measures to prevent the spread of COVID-19. The employees don't have an understanding when they should get paid for time off due to covid related items as their paystubs don't show when that time was different from regular time. Title 8 CCR §3205(c)(5)(B) & (C) & (D) & (F) 6. The employer failed to implement cleaning and disinfecting procedures, which require Identifying and regularly cleaning frequently touched surfaces and objects and cleaning of areas, material, and equipment used by a COVID-19 case during the high-risk exposure period, and disinfection if the area, material, or equipment is indoors and will be used by another employee within 24 hours of the COVID-19 case. These cleanings are not being done as needed' Title 8 CCR §3205(c)(7)(B) 7. The employer failed to exclude COVID-19 cases and employees who had a close contact with COVID-19 cases. This occurred in mid March 2021 and late March/early April 2021 as employees felt their were close contacts.. Title 8CCR §3205(c)(9)(A) & (B)

Alleged Hazards: 6, Employees Exposed: 3
Source: Osha.gov | Receipt Date: 2021-09-14
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AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 … See More
Nationwide to Wholesalers. To date, AvKARE has not received any reports of adverse events related to this recall.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC. Consumers that have product which is being recalled should stop using the product and return it to place of purchase.

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

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: AvKARE, LLC
Brand name: AVpak
Product recalled: Atovaquone Oral Suspension, USP 750mg/5mL
Reason of the recall: Potential Bacillus cereus contamination
FDA Recall date: April 01, 2024

Source: www.fda.gov
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