AMPICILLIN
Generic: AMPICILLIN
Aurobindo Pharma LimitedManufacturer
ORALRoute
AMPICILLIN TRIHYDRATEActive Substance
2023-10-31Original Approval
AMPICILLIN is FDA application ANDA216554, sponsored by AUROBINDO PHARMA. 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
Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10cGMP deviations: Temperature abuse
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 III2017-09-25
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NLabeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pac
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
939 reports
2
FOETAL EXPOSURE DURING PREGNANCY
673 reports
3
DRUG HYPERSENSITIVITY
622 reports
4
MATERNAL EXPOSURE DURING PREGNANCY
547 reports
5
PREMATURE BABY
523 reports
6
OFF LABEL USE
484 reports
7
PYREXIA
445 reports
8
ACUTE KIDNEY INJURY
358 reports
9
PREMATURE DELIVERY
344 reports
10
RENAL FAILURE
330 reports