MAXITROL
Generic: NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE, NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Novartis Pharmaceuticals CorporationManufacturer
OPHTHALMICRoute
NEOMYCIN SULFATEActive Substance
1963-07-19Original Approval
MAXITROL is FDA application NDA050065, sponsored by SANDOZ. 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 III2019-10-17
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured bLabeling: Incorrect or missing package insert.
Class II2022-04-13
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-cGMP deviations: Temperature abuse
Top Reported Reactions
1
EYE IRRITATION
41 reports
2
VISION BLURRED
26 reports
3
OCULAR HYPERAEMIA
23 reports
4
EYE PAIN
22 reports
5
CONDITION AGGRAVATED
14 reports
6
OFF LABEL USE
14 reports
7
HYPERSENSITIVITY
12 reports
8
VISUAL IMPAIRMENT
11 reports
9
EYE SWELLING
10 reports
10
DRUG INEFFECTIVE
9 reports