Label: CEFOTAXIME- cefotaxime injection powder, for solution

  • NDC Code(s): 21586-011-01, 21586-011-02, 21586-012-01, 21586-012-02
  • Packager: SteriMax Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

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.

Drug Label Information

Updated August 1, 2019

If you are a consumer or patient please visit this version.

  • IMPORTANT PRESCRIBING INFORMATION

    July 09, 2019

    Temporary Importation of Cefotaxime for Injection to Address Drug Shortage

    Dear Healthcare Professional:

    Due to the current critical shortage of Cefotaxime for Injection products in the United States (U.S.) market, SteriMax Inc. (SteriMax), in conjunction with Apollo Pharmaceuticals USA Inc. (Apollo) and FFF Enterprises (FFF), is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. SteriMax has initiated temporary importation of non-FDA approved Cefotaxime for Injection (1 g/vial, and 2 g/vial) into the U.S. market. The Cefotaxime for Injection from SteriMax is marketed in Canada and is manufactured at an FDA-inspected facility that complies with current Good Manufacturing Practice requirements.

    At this time, no other entity except Apollo or its distributor FFF is authorized by the FDA to import or distribute SteriMaxs Cefotaxime for Injection in the United States. FDA has not approved SteriMaxs Cefotaxime for Injection in the United States.

    Effective immediately, FFF will distribute the following presentations of SteriMaxs Cefotaxime for Injection to address the critical shortage:

    SteriMax Cefotaxime for Injection

    1 g/vial (as cefotaxime sodium)

    DIN: 02434091

    (Canada)

    2 g/vial (as cefotaxime sodium)

    DIN: 02434105

    (Canada)

    Note: DIN refers to Drug Identification Number for products approved by Health Canada

    The barcode on the imported product label may not register accurately on the U.S. scanning systems. Institutions should manually input the imported product information into their systems and confirm that the barcode, if scanned, provides correct information. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.

    In addition, the packaging of the imported product does not include serialization information. SteriMax’s Cefotaxime for Injection does not meet the Drug Supply Chain Security Act (DSCSA) requirements for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs

    The vial and carton labels will display the text used and approved for marketing the products in Canada with both English and French translations. It is important to note that there are differences in the format and content of the labeling between the US approved product and SteriMax’s Cefotaxime for Injection.  Please see the product comparison tables at the end of this letter.

    Cefotaxime for Injection is available only by prescription in the U.S.Please refer to the package insert for the FDA-approved Cefotaxime for Injection drug product for full prescribing information.

    Finally, please ensure that your staff and others in your institution who may be involved in the administration of Cefotaxime for Injection receive a copy of this letter and review the information.

    If you have any questions about the information contained in this letter, any quality related problems, or questions on the use of SteriMax’s Cefotaxime for Injection, please contact SteriMax Inc. Customer Service at 1-800-881-3550.

    To place an order, please contact FFF Enterprises at1-800-843-7477.

    Healthcare providers should report adverse events associated with the use of SteriMax’s Cefotaxime for Injection to Apollo at 1-833-727-6556.

    Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

    1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

    We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.

    Sincerely,

    signature

    James Booker

    Head of Quality

    SteriMax Inc.

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  • Cefotaxime for Injection - 1 g per vial

    Sterile/Stérile DIN 02234091

    cefoTAXime sodium for Injection BP

    1 g per vial

    Cefotaxime sodium powder for solution

    Intramuscular or Intravenous Use

    Antibiotic/Antibiotique

    LATEX FREE/SANS LATEX

    STERIMAX

    1gvial

  • Cefotaxime for Injection - 2 g per vial

    Sterile/Stérile DIN 02434105

    cefoTAXime sodium for Injection BP

    2 g per vial

    Cefotaxime sodium powder for solution

    Intramuscular or Intravenous Use

    Antibiotic/Antibiotique

    LATEX FREE/SANS LATEX

    STERIMAX

    2gvial

  • INGREDIENTS AND APPEARANCE
    CEFOTAXIME 
    cefotaxime injection powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21586-011
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7) CEFOTAXIME1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21586-011-0210 in 1 PACKAGE08/01/2019
    1NDC:21586-011-011 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage08/01/2019
    CEFOTAXIME 
    cefotaxime injection powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21586-012
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7) CEFOTAXIME2 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21586-012-0210 in 1 PACKAGE08/01/2019
    1NDC:21586-012-011 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage08/01/2019
    Labeler - SteriMax Inc. (251574851)