MOXIFLOXACIN HYDROCHLORIDE
Generic: MOXIFLOXACIN HYDROCHLORIDE
Aurobindo Pharma LimitedManufacturer
ORALRoute
MOXIFLOXACIN HYDROCHLORIDEActive Substance
2014-03-04Original Approval
MOXIFLOXACIN HYDROCHLORIDE is FDA application ANDA202632, sponsored by AUROBINDO PHARMA LTD. 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 III2018-07-26
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. BaltimorFailed Impurities/Degradation Specifications: An out-of-specification result in the related substanc
Class III2019-02-26
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 7Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to
Class III2019-02-01
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Failed Impurities/Degradation Specifications: Out of specification test results in related substance
Top Reported Reactions
1
OFF LABEL USE
2,234 reports
2
DYSPNOEA
2,137 reports
3
ASTHMA
2,055 reports
4
DRUG HYPERSENSITIVITY
2,017 reports
5
DRUG INEFFECTIVE
2,002 reports
6
PNEUMONIA
1,963 reports
7
VOMITING
1,812 reports
8
WHEEZING
1,655 reports
9
PAIN
1,645 reports
10
RASH
1,516 reports