Elevated risk U.S. Food and Drug Administration

Pfizer Accupril tablets 10mg, 20mg, 40 mg recall: Due to N-Nitroso-Quinapril Content

Recall published 4+ years ago

Due to N-Nitroso-Quinapril Content

Pfizer Prescription & OTC drugs — recalled prescription & otc drugsPfizer Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Pfizer Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. i

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 22, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Pfizer
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg

What the company announced

FOR IMMEDIATE RELEASE - NEW YORK, NY., April 22,2022.

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 mg

Accupril® (Quinapril HCl Tablets) , 20 mg

Accupril® (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: DG1188 · Lot Number: 2022 MAY 31 · Expiration Date: 20 mg · Strength: 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: CK6260 · Lot Number: 2022 MAY 31 · Expiration Date: 40 mg · Strength: 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. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.

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 and then follow the instructions above for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET).

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

  • Contact Center: Pfizer Medical Information · Contact Information: 800-438-1985, option 3 (Mon.- Fri. 8 am-9 pm ET) www.pfizermedinfo.com · Area of Support: For medical questions regarding the product
  • Contact Center: Pfizer Drug Safety · Contact Information: 800-438-1985, option 1 (24 hours a day; 7 days a · Area of Support: To report adverse events and product

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

Regular Mail or Fax: Download form 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.

References:

i https://www.fda.gov/drugs/drug safety and availability information about nitrosamine impurities and medications

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • DR9639
  • DX8682
  • 2022 MAY 31
  • DX6031

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2023 MAR 31
  • 20
  • 40

NDC number

On the carton and again on the bottle or blister label.

  • 0071-0530-23
  • 0071-0532-23
  • 0071-0535-23

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mg
  • 20 mg
  • 40 mg
  • 90 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Pfizer — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: 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 and then follow the instructions above for returning the product to Sedgwick.

Company contact: Pfizer — Consumers: Sedgwick, 888-345-0481 — Media: +1 (212) 733-7410, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Pfizer prescription & otc drugs recalled?

Due to N-Nitroso-Quinapril Content These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. i

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code DR9639, DX8682, 2022 MAY 31; best-by date 2023 MAR 31 or 20. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The notice says: 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 and then follow the instructions above for returning the product to Sedgwick.

Where was the recalled product sold?

It was distributed nationwide.

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