Product: Vegetable

Updated:

Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that … See More
appear to relate to this issue. Lupin discontinued the marketing of Quinapril tablets in September 2022. It was distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets.

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. Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles. The recalled lots are included in the table below:

Product: Quinapril Tablets USP, 20mg
Lot No: G102929
Expiry: 04/2023
NDC: 68180-558-09 (90’s)
UPC: 368180558095
Distribution Dates: 03/15/2021 – 09/01/2022

Product: Quinapril Tablets USP, 40mg
Lot No: G100534, G203071, G100533
Expiry: 12/2022, 12/2022, 03/2024
NDC: 68180-554-09 (90’s)
UPC: 368180554097
Distribution Dates: 03/15/2021 – 09/01/2022

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.

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

Company name: Lupin Pharmaceuticals Inc.
Brand name: Lupin
Product recalled: Quinapril 20 and 40 mg tablets
Reason of the recall: Presence of nitrosamine impurity, N-Nitroso-Quinapril
FDA Recall date: December 21, 2022

Source: www.fda.gov
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#blood #drugs #us #vegetable #meat #ro-tel

N

DreamBones are trash, Arkansas, USA

1 year ago reported by user-ndmd1995

My dog is so sick from these dreambone triple flavor twisties. I had to rush him to vet. He has bloody diarrhea and throwing up all night. Just buy some vegetables or chicken and cook for a treat, cheaper than this crap from China  | Symptoms: Vomiting, Bloody Stool

#dreambonedogtreats #petfood #dogfood #arkansas #us #chicken #vegetable #cooks #chi-chis

East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), … See More
N-Nitroso-Quinapril above the proposed interim limit. Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.

-Affected product:
NDC No.: 65862-162-90, Product Name, strength, and pack: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle, Lot number: QE2021005-A; QE2021010-A, Expiry: 01/2023

Risk Statement: 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. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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

In case you experienced 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.

Company name: Aurobindo Pharma USA, Inc.
Brand name: Aurobindo Pharma USA, Inc.
Product recalled: Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle
Reason of the recall: Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril
FDA Recall date: October 25, 2022

Source: www.fda.gov
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Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including … See More
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.i Accupril is indicated for the treatment of hypertension, to lower blood pressure. 

Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and 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 December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.

NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified 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.

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 against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.

Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022

Source: www.fda.gov
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#blood #recall #drugs #us #vegetable #meat #ro-tel

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. … See More
To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. 

Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. 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.

These products are indicated for the treatment of hypertension.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables in the link below and photos of the products can be found below. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.

- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
- Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
- quinapril and hydrochlorothiazide tablets, 20/25 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
- quinapril HCl/hydrochlorothiazide tablets, 20/25 mg

Pfizer has notified 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.

Company name: Pfizer
Brand name: Accuretic, Greenstone Brand
Product recalled: Accuretic™ (quinapril HCl/hydrochlorothiazide); quinapril and hydrochlorothiazide; and quinapril HCl/hydrochlorothiazide tablets
Reason of the recall: Presence of a nitrosamine, N-nitroso-quinapril
FDA Recall date: March 22, 2022

Source: www.fda.gov
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#blood #pfizer #recall #drugs #us #vegetable #meat #ro-tel

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing … See More
life-threatening inflammation of the heart, could result in infections that could be life-threatening.

To date, Lohxa LLC has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.

Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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

Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022

Check the full recall details on www.fda.gov

Source: FDA
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#recall #drugs #us #vegetable

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 www.fda.gov

Source: FDA
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#recall #pfizer #drugs #us #sub

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 www.fda.gov

Source: FDA
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#pfizer #recall #drugs #us

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: www.fda.gov

Source: FDA
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#pfizer #recall #drugs #us

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 www.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 www.fda.gov

Source: FDA
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#blood #recall #drugs #us

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