AMPICILLIN AND SULBACTAM
Generic: AMPICILLIN SODIUM AND SULBACTAM SODIUM
HospiraManufacturer
INTRAVENOUSRoute
AMPICILLIN SODIUMActive Substance
2006-07-25Original Approval
AMPICILLIN AND SULBACTAM is FDA application ANDA065310, sponsored by SANDOZ. 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 I2018-01-02
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed bPresence of Particulate Matter: A confirmed customer report was received for the presence of visible
Class I2018-05-01
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured Presence of Particulate Matter: confirmed customer report of the presence of visible particulate mat
Top Reported Reactions
1
DRUG INEFFECTIVE
79 reports
2
PYREXIA
72 reports
3
OFF LABEL USE
49 reports
4
PNEUMONIA
49 reports
5
CONDITION AGGRAVATED
42 reports
6
MULTIPLE ORGAN DYSFUNCTION SYNDROME
31 reports
7
SEPSIS
31 reports
8
SEPTIC SHOCK
30 reports
9
ACUTE KIDNEY INJURY
29 reports
10
DYSPNOEA
29 reports