CEFOTAXIME- cefotaxime injection powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7)
Available from:
SteriMax Inc.
Administration route:
INTRAMUSCULAR
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Unapproved drug for use in drug shortage
Authorization number:
21586-011-01, 21586-011-02, 21586-012-01, 21586-012-02

CEFOTAXIME- cefotaxime injection powder, for solution

SteriMax Inc.

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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Temporary Imporation of Cefotaxime for Injection to Address Critical Drug Shortage

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:

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call

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,

James Booker

Head of Quality

SteriMax Inc.

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

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

CEFOTAXIME

cefotaxime injection powder, for solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:2158 6 -0 11

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CEFO TAXIME SO DIUM (UNII: 258 J72S7TZ) (CEFOTAXIME - UNII:N2GI8 B1GK7)

CEFOTAXIME

Packag ing

SteriMax Inc.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2158 6 -0 11-0 2

10 in 1 PACKAGE

0 8 /0 1/20 19

1

NDC:2158 6 -0 11-0 1

1 in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph

Cita tio n

Marke ting Start

Date

Marke ting End

Date

Unappro ved drug fo r use in drug

sho rta ge

0 8 /0 1/20 19

CEFOTAXIME

cefotaxime injection powder, for solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:2158 6 -0 12

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CEFO TAXIME SO DIUM (UNII: 258 J72S7TZ) (CEFOTAXIME - UNII:N2GI8 B1GK7)

CEFOTAXIME

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2158 6 -0 12-0 2

10 in 1 PACKAGE

0 8 /0 1/20 19

1

NDC:2158 6 -0 12-0 1

1 in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph

Cita tio n

Marke ting Start

Date

Marke ting End

Date

Unappro ved drug fo r use in drug

sho rta ge

0 8 /0 1/20 19

Labeler -

SteriMax Inc. (251574851)

Revised: 8/2019

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