The FDA and Merck have recalled additional lots of Banamine and Banamine-S, drugs used to treat dairy and beef cattle with fevers. Banamine is also approved for use in horses and pigs. Routine testing found that particulate matter is present in additional lots of the formula, though Merck has not released information on what the matter consists of or why it has occurred. As of the date of this notice, no adverse events have yet been reported as a result of the contaminated injections.
SUMMARY
Date of Recall:
Updated Announcement: September 29, 2023
Announced: September 1, 2023
Public Notification: September 1, 2023
Name(s) of Drug:
Banamine
Banamine-S
Company Name:
Merck Animal Health
Drug Indication:
Fever in Dairy and Beef Cattle
Product Description
The injectable solution is distributed in clear glass bottles. Each has a gray label affixed with an orange block containing dosage information. Banamine was distributed by animal supply stores and pet pharmacies nationwide.
Reason Recalled
Merck performs routine testing of their products throughout the manufacturing process. During one of these tests, particulate matter was present in the recalled lots. After Merck recalled the initial lots of contaminated medication, they noted additional affected lots and issued an updated recall.
Impacts
Farmers and pet owners who inject the contaminated solution may note increased swelling, redness, irritation, or infection at the injection site. IV (intravenous) administration of the solution may lead to lung damage as the particulate matter travels throughout the animal’s bloodstream.
Recalled Lot Information
Animal owners with bottles of Banamine in their possession should immediately compare the identifying data on the bottle to that listed on the chart below. Additional steps will be required if a bottle matches one of the recalled lots. The four newly recalled lots were distributed between May 3, 2023, and August 17, 2023, and are listed first.
Product Description |
UIN |
NDC |
Lot Number |
Expiration Date |
|
Banamine, 100mL |
065474 | 00061-0851-03 | 3511101 | Dec 2024 |
|
Banamine, 100mL |
065474 |
00061-0851-03 | 3511104 |
Dec 2024 |
|
Banamine, 250mL |
065476 |
00061-0851-04 | 3522101 |
Dec 2024 |
|
Banamine-S, 100mL |
065477 |
0061-1838-30 | 3511103 |
Dec 2024 |
|
Banamine, 100mL |
065474 |
00061-0851-03 | 2834102 |
Oct 2024 |
|
Banamine, 250 mL |
065476 |
00061-0851-04 | 2864102 |
Nov 2024 |
|
Banamine-S, 100mL |
065477 | 0061-1838-30 | 2834103 |
Oct 2024 |
Have you found that your animal’s medication has been recalled? Here’s what you should do:
Consumers
- Do not use the recalled medication. Seek out a replacement vial.
- Monitor your animals for any adverse symptoms and notify your veterinarian if any concerns are noted.
- Consumers with questions may call 1-800-521-5767 Mon-Fri from 8:00 am to 5:00 pm (CDT).
- If your cows are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your veterinarian immediately and notify the FDA by calling 1-888-FDA-VETS or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Call 1-800-521-5767. Notify the manufacturer of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Call 1-800-521-5767. Notify the manufacturer of recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!