Industry

Drug recall: Quinapril HCl recalled due to N-Nitroso-Quinapril Content

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables.

April 28, 2022

452

Last Updated on December 31, 2023 by The Health Master

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.

Click for more articles on Drug Recall

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 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg

NDC	Lot Number	Expiration Date	Strength	Configuration/ Count
0071-0530-23	DR9639	2023 MAR 31	10 mg	1 x 90 count bottle
0071-0532-23	DX8682	2023 MAR 31	20 mg	1 x 90 count bottle
DG1188	2022 MAY 31	20 mg	1 x 90 count bottle
0071-0535-23	DX6031	2023 MAR 31	40 mg	1 x 90 count bottle
CK6260	2022 MAY 31	40 mg	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.

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

Must read

Drug recall: Pfizer recalls some batches of Blood Pressure drug due to this reason

Drug recall: Insulin Glargine recalled due to this reason

Moderna recalls thousands of C-19 vaccine doses

Drug recall: Certain Products recalled due to Microbial Contamination

Drug Recall: IDArubicin Hydrochloride Injection recalled due to this reason

Drug recall: Orphenadrine Citrate 100 mg Extended Release Tablets recalled due to this reason

Also read

DCGI approves these 3 C-19 vaccines for kids aged above five years

Customs Department starts issuing notices to Pharma Exporters

Govt approves 16 applications under PLI schemes for APIs & Medical Devices