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(WWTI) - Pfizer is voluntarily recalling five batches of its hypertension medication Accupril because the pills contain elevated levels of a cancer-causing chemical, according to the Food and Drug Administration (FDA).

The recall was issued due to the presence of a nitrosamine, known as Nnitroso-quinapril. Recent testing found that the amount of nitrosamines within the Accupril tablets was above the level set for an acceptable daily intake, according to the FDA.

“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” the FDA explained. “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.”

Accupril is used to treat hypertension, meaning it is intended to lower blood pressure. It can also be used to manage heart failure as adjunctive therapy when added to conventional therapy like diuretics or digitalis.

“Although long-term ingestion of Nnitroso-quinapril may be associated with potential increased cancer risk in humans, there is no immediate risk to patients taking the medication,” the recall states.

Anyone who regularly takes the medication is encouraged to consult their doctor or health provider about alternative treatment options.

The recalled product lots were distributed nationwide distributors in the United States and Puerto Rico from December 2019 to April 2022.

The full description of the recalled lots is listed below:

The FDA has asked distributors to stop distribution and quarantine the product immediately. Those who received the affected products should contact Sedgwick at 888-345-0481 for instructions on how to return their product and how to receive reimbursement.

 

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Company Announcement

Aurobindo Pharma USA, Inc.: Contact 1-866-850-2876 (Option 2)

Recall being handled by Qualanex: Contact 1-888-504-2014

FOR IMMEDIATE RELEASE – October 24, 2022– 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), 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.

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.

The product label is as shown below:

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 with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

• 1-866-850-2876 (Option 2), 24 hours per day, 7 days per week; or
• This email address is being protected from spambots. You need JavaScript enabled to view it.

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. Any general questions regarding the return of this product please contact Qualanex at 1-888-504- 2014 (live calls received 7:00 am to 4:00 pm M-F CST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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