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Pfizer Accupril (Quinapril HCl) tablets - recalled due to Due to N-Nitroso-Quinapril, USA

2 months ago

United States

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 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: fda.gov

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

In case you experienced harm 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: Vi-Jon, LLC
Brand name: CVS Health
Product recalled: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: June 22, 2022

Source: fda.gov
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Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed below. The products have been found to have... See More incorrect labeling where bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

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Lot: 179642
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Product: Morphine Sulfate Extended-Release Tablets
Strength: 60 mg
Quantity per bottle: 100
NDC: 63629-1089-01
Lot: 179643
Expiration: 08/31/2023

Morphine Sulfate Extended-Release tablets are used to manage severe pain. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with "RD" and "71" on one side and plain on the other side. The 60 mg tablets are round, light orange-colored, film-coated tablets debossed with "RD" and "72" on one side and plain on the other side.

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: Bryant Ranch Prepack Inc.
Brand name: Bryant Ranch Prepack Inc.
Product recalled: Morphine Sulfate 30 mg Extended-Release tablets
Reason of the recall: Incorrect labeling
FDA Recall date: June 29, 2022

Source: fda.gov
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Product: Morphine Sulfate Extended-Release Tablets
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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: Bryant Ranch Prepack Inc.
Brand name: Bryant Ranch Prepack Inc.
Product recalled: Morphine Sulfate 30 mg Extended-Release tablets
Reason of the recall: Incorrect labeling
FDA Recall date: June 29, 2022

Source: fda.gov
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Company name: Plastikon Healthcare, LLC
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Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe (4.5 lb. bag), with sell by date of 10/29/22, due to potential contamination with Salmonella. To date, Freshpet has received no reports of illness, injury,... See More or adverse reaction.

The lot may have sold at limited Walmart stores in Alabama and Georgia; and limited Target stores and other select retailers in Connecticut, Massachusetts, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Puerto Rico, Rhode Island, Vermont, and West Virginia.

Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe (4.5 lb. bag) with Sell by Date 10/29/22. The Sell by date, along with the UPC code, can be found on the bottom and back of each bag. Please see product pictures below for details.

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The Freshpet Team had designated this single lot for destruction, but a small portion of the lot was inadvertently shipped to retailers in limited geographic markets in the last two weeks. No other Freshpet products or lot codes are impacted by this recall.

Salmonella can affect animals eating the product and there is risk to humans, notably children, the elderly, and the immunocompromised, when handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms.

Consumers exhibiting these signs after having contact with this product should contact their healthcare provider. Dogs with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some dogs will have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans.

If your dog has consumed the recalled product and has these symptoms, please contact your veterinarian. If pet parents have products matching the following description and sell by date in their possession, they should stop feeding it to their dogs and dispose of it immediately. Please call the company 1.800.285.0563 Mon. through Fri., 9 am–9 pm (EDT) and Sat. through Sun. 9 am--1 pm (EDT) if you have any of the recalled product.

Company name: Freshpet Inc.
Brand name: Freshpet
Product recalled: Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe
Reason of the recall: Potential Salmonella contamination
FDA Recall date: June 18, 2022

Source: fda.gov
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