Pfizer’s Nationwide Voluntary Recall of Several ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide tablets, and quinapril HCl/hydrochlorothiazide tablets due to their N-Nitroso- Quinapril content

for immediate posting – New York, NY, March 21, 2022.

Pfizer is voluntarily recalling the Accuretic Tablets (quinapril HCl/hydrochlorothiazide) distributed by Pfizer as well as two licensed medications distributed by Greenstone (quinapril, hydrochlorothiazide, and quinapril HCl/hydrochlorothiazide) to the patient (consumer/user) level due to the presence of nitrosamine-quinaprilnitrol , above the acceptable daily intake (ADI). 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.me

These products are prescribed to treat high blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular diseases, especially strokes and myocardial infarctions. Secondly The products have a safety profile built over 20 years of marketing authorization and through a robust clinical program. To date, Pfizer is not aware of the reports of adverse events that have been evaluated as related to this recall. Pfizer believes that the benefits/risks of the products remain positive based on the data currently available. Although long-term administration of N-nitroso-quinapril may be associated with an increased risk of cancer in humans, there is no immediate risk to patients taking this drug. Patients currently taking the products should consult their physician about alternative treatment options.

The NDC, batch number, expiration date and composition details for these products are indicated in the tables below and product images can be found at the end of this press release. The product groups 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

NDC number a lot Expiry date Energy Configuration/Quantity
0071-3112-23 FG5379 08/2024 10 / 12.5 mg 1 bottle number 90
0071-0222-23 EA6686 04/2022 10 / 12.5 mg 1 bottle number 90
0071-5212-23 FG5381 08/2024 20 / 12.5 mg 1 bottle number 90
0071-0220-23 EA6665 04/2022 20 / 12.5 mg 1 bottle number 90
0071-0220-23 CN0640 04/2022 20 / 12.5 mg 1 bottle number 90
0071-0223-23 ET6974 02/2023 20/25 mg 1 bottle number 90

quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20 / 12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg

NDC number a lot Expiry date Energy Configuration/Quantity
59762-5225-9 FE3714 02/2023 20/25 mg 1 bottle number 90
59762-0220-1 DN6931 03/2023 20 / 12.5 mg 1 bottle number 90
59762-0220-1 ED3904 03/2023 20 / 12.5 mg 1 bottle number 90
59762-0220-1 ED3905 03/2023 20 / 12.5 mg 1 bottle number 90
59762-0223-1 DP3414 02/2023 20/25 mg 1 bottle number 90

Pfizer places the utmost emphasis on patient safety and product quality at every step of the manufacturing and supply chain process. Pfizer has notified direct recipients with a letter to arrange the return of any returned product.

Wholesalers and distributors with current stock of the quantities, listed in the table above, must discontinue use and distribution and isolate the product immediately.

If you have distributed the returned product again, please notify any additional accounts or websites that may have received the returned product from you. Please make a sub-recall of those accounts and report this recall information immediately. Please ask them to immediately stop distributing the affected product and immediately contact Sedgwick at 888-843-0247 (Mon-Fri. 8:00 a.m. – 5:00 p.m. ET) to obtain a Action Refund Card (BRC) to begin the return process .

Patients taking this product should consult their healthcare provider or pharmacy to determine if they have the affected product. Patients with an affected product should call Sedgwick at 888-843-0247 (Mon-Fri. 8:00 a.m. – 5:00 p.m. ET) for instructions on how to return their product and get reimbursed for their cost.

Healthcare professionals who have questions regarding this recall may contact Pfizer using the information below.

Contact Center contact information support area
Pfizer medical information

Pfizer drug safety

800-438-1985 Option 3
(Mon-Fri 8 a.m. to 9 p.m. ET)
800-438-1985 Option 1
For medical product related questions

To report adverse events and product complaints

Adverse reactions or quality problems encountered with use of this product may be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program either online, by post, or by fax.

  • Complete and submit the report online
  • Post or Fax: Download the form or call 800-332-1088 to request a reporting form, then complete the address and return it to the previously directed form, or fax it to 1-800-FDA-0178

This recall is made by the US Food and Drug Administration.

References:
me https://www.fda.gov/drugs/drug-safety-andavailability/information-about-nitrosamine-impurities-medications
Secondly William B et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Your Heart J 2018; 39:30213104. doi:10.1093/eurheartj/ehy339.

Appendix A: Product Images

Accuretic™ Tablets (quinapril HCl / hydrochlorothiazide)
Picture2.jpg Picture3.jpg

quinapril and hydrochlorothiazide tablets
Picture4.jpg

Quinapril HCl/Hydrochlorothiazide Tablets
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