CEFAZOLIN

Generic: CEFAZOLIN SODIUM, CEFAZOLIN

Fresenius Kabi USAManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
CEFAZOLIN SODIUMActive Substance
2008-10-22Original Approval

CEFAZOLIN is FDA application ANDA065303, sponsored by ACS DOBFAR. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2022-04-13
Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical In

cGMP deviations: Temperature abuse

Class I2013-11-21
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due t

Class I2025-06-27
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials l

Class II2022-04-13
Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc

cGMP deviations: Temperature abuse

Class I2013-11-21
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due t

Class II2021-03-15
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
HYPOTENSION
702 reports
2
DRUG INEFFECTIVE
668 reports
3
ANAPHYLACTIC REACTION
644 reports
4
ANAPHYLACTIC SHOCK
601 reports
5
RASH
592 reports
6
PYREXIA
513 reports
7
RENAL FAILURE
488 reports
8
ACUTE KIDNEY INJURY
432 reports
9
OFF LABEL USE
413 reports
10
PAIN
413 reports