VITALIPID N- vitamin a palmitate, ergocalciferol, .alpha.-tocopherol, dl-, phytonadione emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC), .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

VITALIPID N- VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL,
DL-,
PHYTONADIONE EMULSION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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FRESENIUS KABI USA, LLC
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300
September 1, 2023
www.fresenius-kabi.us
IMPORTANT PRESCRIBING INFORMATION
Subject:
Temporary importation of Vitalipid N ADULT and Vitalipid N INFANT to
address
drug shortage. The product is also labeled as Vitlipid N ADULT and
Vitlipid N
INFANT.
Dear Healthcare Professional,
Due to the critical shortage of parenteral multivitamins in the U.S.
market, Fresenius Kabi
USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and
Drug
Administration (FDA) to provide an alternative treatment option during
this time.
Fresenius Kabi USA has initiated temporary importation of Vitalipid
Injection 10 mL Single
Dose Glass Ampule into the U.S. market. The products imported into the
U.S. may also
be labeled with a slight variation of the proprietary name, Vitlipid N
ADULT and Vitlipid N
INFANT, depending on which country the product was originally
intended. Other than
the slight variation in the proprietary name, the products are
identical, and the products
will be referred to as Vitalipid N ADULT and Vitalipid N INFANT for
the remainder of this
letter. Vitalipid N ADULT and Vitalipid N INFANT are sterile
oil-in-water emulsions
containing fat-soluble vitamins in the oil phase. This product is
marketed in Europe and is
manufactured in the Fresenius Kabi Uppsala, Sweden plant.
At this time, no other entity except Fresenius Kabi USA is authorized
by the FDA to
import or distribute Vitalipid Injection 10 mL Single Dose Glass
Ampules (One Point Cut)
in the U.S. The FDA has not approved Fresenius Kabi's Vitalipid
product for marketing in
the United States.
This communication and product information is availab