Elevated risk U.S. Food and Drug Administration

Lupin Quinapril 20 and 40 mg tablets recall: Presence of nitrosamine impurity, N-Nitroso-Quinapril

Recall published 3+ years ago

Presence of nitrosamine impurity, N-Nitroso-Quinapril

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

The hazard: Harmful chemical exposure

The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

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.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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
December 21, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Lupin
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
368180558095, 368180554097
Reports of harm
To date, Lupin has received no reports of illness that appear to relate to this issue.

Products covered by this recall

Quinapril 20 and 40 mg tablets

What the company announced

Baltimore, Maryland, December 21, 2022: Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.

Lupin discontinued the marketing of Quinapril tablets in September 2022.

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.

Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:

  • Product: Quinapril Tablets USP, 20mg · Lot No: G102929 · Expiry: 04/2023 · NDC: 68180-558-09 (90’s) · UPC: 368180558095 · Distribution Dates: 03/15/2021 – 09/01/2022
  • Product: Quinapril Tablets USP, 40mg · Lot No: G100533 G100534 G203071 · Expiry: 12/2022 12/2022 03/2024 · NDC: 68180-554-09 (90’s) · UPC: 368180554097

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (877) 538-8445 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.

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

https://www.fda.gov/safety/report-problem-fda

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

Product Label: (see images below)

About Lupin Pharmaceuticals

Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.’s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women’s health conditions with serious health consequences.

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

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 368180558095
  • 368180554097

Lot or batch code

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

  • G102929
  • G100533 G100534 G203071
  • 20mg
  • 40mg

Best-by / use-by date

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

  • 04/2023
  • 12/2022 12/2022 03/2024

NDC number

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

  • 68180-558-09
  • 68180-554-09

Model or item number

On the rating label, the box or the instruction sheet.

  • 20mg
  • 40mg

Package size

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

  • 40 mg
  • 20 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 Chemical

Lupin — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

  1. Stop using the product and keep it away from children and pets.
  2. Ventilate the room if the product was sprayed or applied there.
  3. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  4. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Lupin Pharmaceuticals Inc. — Consumers: Inmar Rx Solutions, Inc., 877-538-8445

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 Lupin prescription & otc drugs recalled?

Presence of nitrosamine impurity, N-Nitroso-Quinapril These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 368180558095, 368180554097; lot code G102929, G100533 G100534 G203071, 20mg; best-by date 04/2023 or 12/2022 12/2022 03/2024; model number 20mg, 40mg. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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