Elevated risk U.S. Food and Drug Administration

Merck Animal Health Banamine recall: Potential presence of particulate matter

Recall published 3+ years ago

Potential presence of particulate matter

Merck Animal Health Veterinary drugs — recalled veterinary drugsMerck Animal Health Veterinary drugs — recalled veterinary drugs (photo 2)Merck Animal Health Veterinary drugs — recalled veterinary drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — foreign objects

This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: The administration of an injectable product that contains particulate matter may result in local irritation, swelling or infection in response to the foreign material.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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
September 1, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Merck Animal Health
Product type
Veterinary drugs
Reports of harm
To date, no adverse event reports have been received for the recalled batches.

Products covered by this recall

Banamine; Banamine-S

What the company announced

RAHWAY, N.J., Sept. 1, 2023 – Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA. (NYSE:MRK), is voluntarily recalling three batches of BANAMINE®/BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses to the consumer level due to the presence of particulate matter. BANAMINE® /BANAMINE®-S (flunixin meglumine injection) is a prescription product in the U.S.

Particulates were observed during routine quality testing and reviews for the following batches:

BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 2834102, exp Oct. 2024

o Distribution dates: March 6, 2023, to May 3, 2023

BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 2864102, exp Nov. 2024

o Distribution dates: June 21, 2023, to July 11, 2023

BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 2834103, exp Oct. 2024

o Distribution dates: March 20, 2023, to May 16, 2023

A photo of the bottle of each batch number (lot number) that is part of the recall can be found at the end of this press release. The lot number (LOT) and expiry date (EXP) is located at the bottom right part of the bottle label.

The administration of an injectable product that contains particulate matter may result in local irritation, swelling or infection in response to the foreign material. After intravenous administration in large animals, such as cattle or horses, particulate matter could travel to the lungs which could result in local tissue damage. To date, no adverse event reports have been received for the recalled batches.

Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is approved in the US only for intravenous use in beef and dairy cattle, for intravenous and intramuscular use in horses and for intramuscular use in swine.

Customers who have received BANAMINE and BANAMINE®-S from the batches being recalled should stop using the products and refer to their recall letter for product return instructions. Merck Animal Health is working with our distributor partners to ensure that unused product is no longer in distribution or with customers. We are notifying our distributors and customers directly and are arranging for the return of all recalled product.

Consumers with questions regarding this recall should call 1-800-521-5767 (Monday through Friday 8 a.m. – 5 p.m. CDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA at 1-888-FDA-VETS or online at http://www.FDA.gov/reportanimalae .

This recall is being made with the knowledge of the Food and Drug Administration.

The health and well-being of animals is the foremost priority at Merck Animal Health. We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process.

About Merck Animal Health

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of HealthierAnimals® , Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn , Facebook , Twitter and Instagram .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ) .

Expanded Recall

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 11 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.

  • 2834102
  • 2864102
  • 2834103

Best-by / use-by date

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

  • Oct. 2024
  • Nov. 2024

NDC number

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

  • 00061-0851-03
  • 00061-0851-04
  • 0061-1838-30

Package size

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

  • 50 mg
  • 100 mL
  • 250 mL

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 Foreign material

Merck Animal Health — This is a foreign-material recall — foreign objects where there should be none. An affected pack looks identical to a sound one from the outside.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  3. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  4. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval…

Company contact: Merck Animal Health — Consumers: 1-800-521-5767 — Media: Tom Schad, (816) 721-7547, [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 Merck Animal Health veterinary drugs recalled?

Potential presence of particulate matter The administration of an injectable product that contains particulate matter may result in local irritation, swelling or infection in response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2834102, 2864102, 2834103; best-by date Oct. 2024 or Nov. 2024. 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 eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and…

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