Fort Dodge Laboratories Inc: Various Veterinary Injections Recalled Due to Sterility Concerns

Agency Publication Date: July 20, 2004

Summary

Fort Dodge Laboratories is recalling approximately 428,100 units of several veterinary medications, including Amiglyde-V, Cal-Dextro, Factrel, Flucort, Ketaset, ProHeart 6, and Torbugesic, due to manufacturing deviations discovered during an inspection. These deviations mean the sterility of these injectable products cannot be guaranteed, which could lead to infections in treated animals. The affected products were distributed nationwide to veterinarians and clinics, as well as to several international markets.

Risk

If an injectable medication is not sterile, it may contain bacteria or other contaminants that can cause serious infections, abscesses, or systemic illness at the site of injection or within the animal's body.

What You Should Do

Identify if you have any of the affected products: Amiglyde-V (50-mL), Cal-Dextro No. 2 or Special (500-mL), Factrel (20/50-mL), Flucort (100-mL), Vetalar/Ketaset (10-mL), ProHeart 6 (5 or 10-packs), PromAce (50-mL), or Torbugesic (10/50-mL).
Check the labels for NDC numbers including 0856-2326-20, 0856-0263-01, 0856-0271-01, 0856-4311-02, 0856-0820-20, 0856-2012-01, 0856-3670-25, 0856-3670-20, 0856-3020-01, or 0856-2033-20.
Immediately stop using these injectable medications and quarantine any remaining stock to ensure they are not administered to animals.
Contact your veterinarian or pharmacist for guidance regarding the health of animals that have recently received these injections.
Return any unused product to the place of purchase or the distributor for a refund and contact Fort Dodge Laboratories for further return instructions.
For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-276-9300.

Your Remedy Options

Full Refund

Veterinary drug refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fort Dodge Amiglyde-V Injection, Amikacin Sulfate (50-mL vial)

Model:

NADA 127-892

UPC Codes:

0856232620

Product: Fort Dodge Cal-Dextro No. 2 Sterile Solution (500-mL bottle)

UPC Codes:

0856026301

Product: Fort Dodge Cal Dextro Special Sterile Solution (500-mL bottle)

UPC Codes:

0856027101

Product: Fort Dodge Factrel, Gonadorelin Hydrochloride (20 mL and 50 mL vials)

Model:

NADA 139-237

UPC Codes:

0856431102

Product: Fort Dodge Flucort Flumethasone Solution (100-mL vial)

Model:

NADA 030-414

UPC Codes:

0856082020

Product: Ketamine Hydrochloride Injection (Vetalar and Ketaset) (10-mL vial)

Model:

NADA 045-290

UPC Codes:

0856201201

Product: Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs (5-pack and 10-pack)

Model:

NADA 141-189

UPC Codes:

0856367025

0856367020

Product: Fort Dodge PromAce Injectable, Acepromazine Maleate Injection (50-mL vial)

Model:

NADA 015-030

UPC Codes:

0856302001

Product: Fort Dodge Torbugesic Butorphanol Tartrate Veterinary Injection (10-mL and 50-mL vials)

Model:

NADA 135-780

UPC Codes:

0856203320

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 29043

Status: Active

Manufacturer: Fort Dodge Laboratories Inc

Sold By: veterinarians; veterinary clinics; veterinary drug distributors

Manufactured In: United States

Units Affected: 9 products (2,321 vials; 62,170 bottles; 7,020 bottles; 14,830/20-mL and 2,747/50-mL vials; 8,768 vials; 5,000/10-mL vials Vetalar and 221,537/10-mL. vials Ketaset; 78,344 vials; 13,365 vials; 17,039/10-mL vials and 9,955/50-mL vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Identify if you have any of the affected products: Amiglyde-V (50-mL), Cal-Dextro No. 2 or Special (500-mL), Factrel (20/50-mL), Flucort (100-mL), Vetalar/Ketaset (10-mL), ProHeart 6 (5 or 10-packs), PromAce (50-mL), or Torbugesic (10/50-mL).

Check the labels for NDC numbers including 0856-2326-20, 0856-0263-01, 0856-0271-01, 0856-4311-02, 0856-0820-20, 0856-2012-01, 0856-3670-25, 0856-3670-20, 0856-3020-01, or 0856-2033-20.

Immediately stop using these injectable medications and quarantine any remaining stock to ensure they are not administered to animals.

Contact your veterinarian or pharmacist for guidance regarding the health of animals that have recently received these injections.

Return any unused product to the place of purchase or the distributor for a refund and contact Fort Dodge Laboratories for further return instructions.

For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-276-9300.

Affected Products

Product: Fort Dodge Amiglyde-V Injection, Amikacin Sulfate (50-mL vial)

Model:

NADA 127-892

UPC Codes:

0856232620

Product: Fort Dodge Cal-Dextro No. 2 Sterile Solution (500-mL bottle)

UPC Codes:

0856026301

Product: Fort Dodge Cal Dextro Special Sterile Solution (500-mL bottle)

UPC Codes:

0856027101

Product: Fort Dodge Factrel, Gonadorelin Hydrochloride (20 mL and 50 mL vials)

Model:

NADA 139-237

UPC Codes:

0856431102

Product: Fort Dodge Flucort Flumethasone Solution (100-mL vial)

Model:

NADA 030-414

UPC Codes:

0856082020

Product: Ketamine Hydrochloride Injection (Vetalar and Ketaset) (10-mL vial)

Model:

NADA 045-290

UPC Codes:

0856201201

Product: Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs (5-pack and 10-pack)

Model:

NADA 141-189

UPC Codes:

0856367025

0856367020

Product: Fort Dodge PromAce Injectable, Acepromazine Maleate Injection (50-mL vial)

Model:

NADA 015-030

UPC Codes:

0856302001

Product: Fort Dodge Torbugesic Butorphanol Tartrate Veterinary Injection (10-mL and 50-mL vials)

Model:

NADA 135-780

UPC Codes:

0856203320

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 29043

Status: Active

Manufacturer: Fort Dodge Laboratories Inc

Sold By: veterinarians; veterinary clinics; veterinary drug distributors

Manufactured In: United States

Distributed To: Nationwide