RIFAMPIN

Generic: RIFAMPIN

Lupin PharmaceuticalsManufacturer
ORALRoute
RIFAMPINActive Substance
2013-08-21Original Approval

RIFAMPIN is FDA application ANDA090034, sponsored by LUPIN PHARMS. 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 II2022-07-28
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore,

CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.

Class II2015-06-04
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, L

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradat

Class II2024-01-05
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla

Subpotent Drug and Failed Impurities/Degradation Specifications

Class II2024-01-05
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Marylan

Subpotent Drug and Failed Impurities/Degradation Specifications

Class II2022-04-07
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga

Failed Impurities/Degradation Specifications: High out of specification results obtained for related

Class II2022-12-12
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 212

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during l

Class II2019-10-07
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 6

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results

Top Reported Reactions

1
DRUG INEFFECTIVE
1,608 reports
2
OFF LABEL USE
1,216 reports
3
DRUG INTERACTION
1,084 reports
4
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
746 reports
5
NAUSEA
680 reports
6
CONDITION AGGRAVATED
619 reports
7
PRODUCT USE IN UNAPPROVED INDICATION
594 reports
8
PYREXIA
571 reports
9
VOMITING
485 reports
10
DRUG RESISTANCE
461 reports