METRONIDAZOLE
Generic: METRONIDAZOLE
Alembic Labs LLCManufacturer
ORALRoute
METRONIDAZOLEActive Substance
2017-06-20Original Approval
METRONIDAZOLE is FDA application ANDA208681, sponsored by ALEMBIC. 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 I2016-01-21
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Presence of Particulate Matter: identified as a cloth fiber.
Class II2013-05-21
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for pote
Top Reported Reactions
1
DRUG INEFFECTIVE
4,557 reports
2
NAUSEA
3,428 reports
3
OFF LABEL USE
3,311 reports
4
DIARRHOEA
2,687 reports
5
VOMITING
2,300 reports
6
PYREXIA
2,260 reports
7
HEADACHE
2,215 reports
8
PAIN
2,098 reports
9
ABDOMINAL PAIN
2,091 reports
10
FATIGUE
1,928 reports