FerroForte

Manufacturer
Vetoquinol N.-A. INC | Bimeda-MTC Animal Health | Serumwerk Bernburg AG
Effective date
2020-12-01
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:04:46

Label at a glance#

ProductFerroForte
Active ingredientIRON DEXTRAN
Label structure10 sections

Storage and handling

STORAGE: Store at room temperature (15°-30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Bimeda-MTC

Sterile Iron Dextran for Injection

200 mg/mL

Veterinary Use Only

DIN 00857041

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT: FerroForte® is a clear, free flowing dark brown solution containing a macromolecular dextran and iron complex containing 200 mg/mL elemental iron with 0.5% w/v phenol as a preservative.

VETERINARY INDICATIONS SECTION

INDICATIONS: For the prevention and treatment of iron deficiency anemia in newborn piglets.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: Inject 1 mL (200 mg iron) intramuscularly at one (1) to three (3) days of age. Disinfect the site of injection.

STORAGE AND HANDLING SECTION

STORAGE: Store at room temperature (15°-30°C).

SPL UNCLASSIFIED SECTION

Manufactured by:
Bimeda-MTC Animal Health Inc., Cambridge ON, N3C 2W4

Distributed by:
Vetoquinol N.-A. Inc.
2000, ch. Georges, Lavaltrie, QC, CANADA J5T 3S5
vetoquinol

SPL PATIENT PACKAGE INSERT SECTION

Client Information Sheet
FerroForte®

FerroForte® is a sterile Iron Dextran for Injection (200 mg/mL) supplied in 100 mL bottles for veterinary use only. FerroForte® is not approved by the FDA.

FDA has agreed to allow Vetoquinol N.-A. Inc. to supply FerroForte® in order to help address the anticipated shortage of Iron Dextran Injection, 200 mg/mL for prevention and treatment of iron deficiency anemia in newborn piglets in the U.S.A.

FerroForte® is approved by Health Canada and exported to the U.S.A. by Vetoquinol N.-A. Inc.

FerroForte® should be used according to the details of the Compendium text provided in the back of this Client Information Sheet. You can use FerroForte® as you would use any other Iron Dextran for Injection in the prevention and treatment of iron deficiency in newborn piglets in the U.S.A. For example, site of administration as illustrated below.

SPL PATIENT PACKAGE INSERT SECTIONSPL PATIENT PACKAGE INSERT SECTION

ADVERSE DRUG EVENTS & PRODUCT DEFECTS

ADVERSE REACTIONS SECTION

To report suspected adverse drug events and product defects, please contact Vetoquinol N.-A.'s toll-free number at 1-800-363-1700 and inform the representative that your call concerns the Canadian product, FerroForte® . For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

Vetoquinol N.-.A. Inc.
2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5
vetoquinol

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FerroForte®

Sterile Iron Dextran
for Injection
200 mg/mL
Veterinary Use
Only

Net 100 mL

DIN 00857041
1FER005

vetoquinol

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59320-10059320-100-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
IRON DEXTRAN95HR524N2MACTIM
PHENOL339NCG44TVIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFEDIRON DEXTRANHenry Schein, Inc.99bf34be-cb8a-46d1-9637-5544dc2da2872026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN
IRON DEXTRANIRON DEXTRANHF Acquisition Co LLC, DBA HealthFirst9a4cd424-865d-fdd1-e053-2995a90a00ff2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN
INFeDIRON DEXTRANAllergan, Inc.94b01b1e-794b-4bea-8e24-2e54683fc0232024-08-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRON DEXTRAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.