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Product: Vegetable

Updated: September 16, 2021 9:02 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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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
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Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above ADI level
FDA Recall date: July 19, 2021
Recall details: Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and... See More eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (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 product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021. 

For more recall details including the NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets check: fda.gov

Source: FDA
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Company name: Viona Pharmaceuticals Inc.
Brand name: Viona Pharmaceuticals Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets
Reason of the recall: Contains Nitrosodimethylamine (NDMA) impurities
FDA Recall date: June 11, 2021
Recall details: Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP... See More 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at fda.gov To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are listed in the below table. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg. NDC No: 72578-036-01. Batch No: M915601. Exp. Date: Oct-2021.

Check the full recall details on fda.gov

Source: FDA
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I think my dog was harmed. I had never given her a "dog bone' before. The package read that it is made from Vegetables and Chicken. I gave it to her and five minutes later checked on her just in time to see her swallow the last... See More of it. How much she swallowed whole I don't know. But within one day she was not having bowel movements and was throwing up any food I gave her. This started April 28, 2021. She is still not well and under the veterinarians care | Symptoms: Vomiting, Other See Less

Company name: Nostrum Laboratories, Inc.
Brand name: Nostrum Laboratories, Inc.
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
FDA Recall date: January 25, 2021
Recall details: Kansas City,... See More Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide in the USA to wholesalers who further distributed to pharmacies and patients.

- Product Description: Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)
- NDC: 29033-056-01
- Lot Number: MET200601
- Expiry Dates: 07/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA
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Facility open to public. Buyers for local grocery stores and supermarkets pulling/picking own boxes of fruits and vegetables. Truck drivers entering warehouse and using our restrooms. No masks on hand. Gloves not in a common area for employees to access. Social distancing not being enforced


Source: Osha.gov... See More | Receipt Date: 2020-03-27 See Less

The FSA announced the recall of several dog food products by Mars Petcare UK because they may contain high levels of vitamin D which exceed the maximum permitted intake.

FSA advises pet owners that if they have bought any of the following dog food products, you should... See More stop feeding them to your dog and contact Mars Petcare Customer Service at 0800 013 3131. If you have concerns that your pet may be showing symptoms of illness after eating one of the affected products, please contact a veterinarian.

- CHAPPIE Complete Chicken & Wholegrain Dry Dog Food (3kg). Batch code: 045F9MIN05. Best before: 44692
- PEDIGREE Mixer Adult Dry Dog Original (3kg). Batch code: 046E9MIN05 | 046F9MIN05 | 048A9MIN05. Best before: 12 February 2022 | 20 February 2022 | 22 February 2022
- PEDIGREE Mixer Adult Dry Dog Food Original (10kg). Batch code: 046E9MIN08 | 047C9MIN08. Best before: 12 February 2022 | 17 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (12kg). Batch code: 046C9MIN08 | 046D9MIN08 | 046E9MIN08. Best before: 10 February 2022 | 11 February 2022 | 12 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (2.6kg). Batch code: 045F9MIN05 | 047A9MIN05. Best before: 06 February 2022 | 15 February 2022

High levels of vitamin D fed to a pet over a short period (weeks/months) should not cause undue concern. Over a longer period of feeding, ingestion of elevated levels can lead to potential dog health issues. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction.

Check the full recall details on the FSA website food.gov.uk

Source: FSA
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Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: January 04, 2021
Recall details: Company Announcement Nostrum Laboratories, Inc. is voluntarily recalling one lot of... See More Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. This is an expansion of the recall initially announced on November 2, 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall. The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide to wholesalers.
Check the full recall details on fda.gov
Source: FDA
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