NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Generic: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
NorthStar RxLLCManufacturer
ORALRoute
NITROFURANTOIN MONOHYDRATEActive Substance
2023-07-11Original Approval
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is FDA application ANDA217357, sponsored by MANKIND 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 II2019-07-24
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. PineFailed dissolution specifications
Class II2015-04-21
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. PiFailed Dissolution Specification; 6 month time point
Class III2018-11-02
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); Cross Contamination with Other Products
Class II2018-12-21
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., SomersSubpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification
Class II2018-06-28
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. SomersetSubpotent Drug and Failed Content Uniformity.
Top Reported Reactions
1
URINARY TRACT INFECTION
1,440 reports
2
FATIGUE
1,343 reports
3
NAUSEA
1,285 reports
4
HEADACHE
1,197 reports
5
DYSPNOEA
1,041 reports
6
PAIN
1,023 reports
7
DIARRHOEA
943 reports
8
RASH
906 reports
9
MALAISE
891 reports
10
VOMITING
876 reports