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Product: Meat

Updated: September 16, 2021 12:00 PM
Company name: Pfizer
Brand name: CHANTIX
Product recalled: Varenicline tablets
Reason of the recall: N-nitroso-varenicline above acceptable daily intake level
FDA Recall date: September 16, 2021
Recall details: Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level... See More due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. Check the link below for the full list of the recalled products.

The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options.

To date, Pfizer has not received reports of adverse events assessed to be related to this recall. The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets are indicated in Appendix A. Photos of the products can be found in Appendix B.

The products were distributed nationwide to Wholesalers and Distributors in the United States, US Virgin Islands, and Puerto Rico from May 2019 to September 2021. Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and Distributors with an existing inventory of Chantix tablets, should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately. Additionally, if you are aware of any patients to whom you dispensed the products and who still may have the product in their possession, please ask them to return the product.

As communicated by FDA, there is no immediate risk to patients taking Chantix.iv Patients who are taking this product should consult with their health care provider to determine if alternative treatments are available.

Check the full recall details on fda.gov

Source: FDA
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Allegation 1) Employees who provide ambulatory care to confirmed and suspected COVID-19 patients are required to wear N95 respirators and have not completed an initial fit test. Allegation 2) Employees are provided with disposable mesh gowns that are inadequate. The gowns become saturated, allowing infectious material to... See More permeate through the material. Allegation 3) The employer, after learning that an employee was confirmed positive for COVID-19, did not inform affected employees, of their potential exposure to COVID-19. The affected employees worked alongside an employee who tested positive for COVID-19.

Alleged Hazards: 3, Employees Exposed: 50
Source: Osha.gov | Receipt Date: 2020-11-17
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7 individuals at D&L Meat in Sedgwick county tested positive for Covid-19. The outbreak began on 19-08-2021

Source: colorado.gov See Less

T8CCR§3203(a) & §3362 Store is overcrowded and there is insufficient social distancing. There is no social distancing in the meat department. Several employees in the meat department have contracted COVID-19. Common surfaces are not sanitized frequently to prevent the spread of COVID-19.

Alleged Hazards: 2, Employees Exposed:... See More 1
Source: Osha.gov | Receipt Date: 2020-10-20
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1. One employee die from COVID on Friday the 16th of April. 2. There are about 7 or 8 employees out with COVID-19 right now and probably another 20 to 25 more employees that were exposed to them, but it is unclear if any of them have... See More COVID-19 or if they were reported. 3. They don't clean the bathrooms any extra like wiping down the stalls, sinks, faucets, and the mirrors. 4. They don't wipe down the registers, the conveyor belts, they don't wipe down the plastic barrier, they don't clean the glass doors in the cold/freezer departments, they don't wipe down the bunkers in the meat department and they don't clean the shopping carts.


Source: Osha.gov | Receipt Date: 2021-04-19
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An employee(1) at STAMPEDE MEAT INC in SANTA TERESA, NM tested positive for Covid-19 and the company is on the Rapid Response COVID-19 Watchlist Event Date: 08/18/2021,

Source: env.nm.gov See Less

They are not complying with the blue lines on floor to keep distance between everyone... No employee in the meat or deli dept or cashiers are wearing gloves or masks or hair nets


Source: Osha.gov | Receipt Date: 2020-03-31 See Less

Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above acceptable daily intake level
FDA Recall date: August 16, 2021
Recall details: Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient... See More (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program.

Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.

To date, Pfizer has not received any reports of adverse events that have been related to this recall. The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below with the four additional lots. Photos of the products can be found at the end of this press release.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021. You can see the recalled products in the link below.

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

Check the full recall details on fda.gov

Source: FDA
See Less

Multiple employees(2) at STAMPEDE MEAT INC in SANTA TERESA, NM tested positive for Covid-19 and the company is on the Rapid Response COVID-19 Watchlist Event Date: 08/10/2021,

Source: env.nm.gov See Less