NEOMYCIN SULFATE
Generic: NEOMYCIN SULFATE
Solaris Pharma CorporationManufacturer
ORALRoute
NEOMYCIN SULFATEActive Substance
2006-07-28Original Approval
NEOMYCIN SULFATE is FDA application ANDA065220, sponsored by AMVIKA. 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 II2022-08-23
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North WCGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingred
Class II2021-03-15
NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North WaleCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
DRUG HYPERSENSITIVITY
507 reports
2
DRUG INEFFECTIVE
392 reports
3
PAIN
347 reports
4
OFF LABEL USE
269 reports
5
NAUSEA
265 reports
6
DYSPNOEA
252 reports
7
MALAISE
243 reports
8
INFUSION RELATED REACTION
241 reports
9
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
225 reports
10
MACULAR DEGENERATION
202 reports