LOTEPREDNOL ETABONATE AND TOBRAMYCIN
Generic: LOTEPREDNOL ETABONATE AND TOBRAMYCIN
Bausch & Lomb Americas Inc.Manufacturer
OPHTHALMICRoute
LOTEPREDNOL ETABONATEActive Substance
2004-12-14Original Approval
LOTEPREDNOL ETABONATE AND TOBRAMYCIN is FDA application NDA050804, sponsored by BAUSCH AND LOMB. 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 II2024-02-22
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE Failed Stability Specification: Water determination was found not complying with specification.
Class III2023-07-27
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ Failed Impurities/Degradation Specifications
Top Reported Reactions
1
OFF LABEL USE
813 reports
2
PNEUMONIA
792 reports
3
DRUG INEFFECTIVE
751 reports
4
ACUTE KIDNEY INJURY
706 reports
5
DYSPNOEA
695 reports
6
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS
622 reports
7
DEATH
494 reports
8
CONDITION AGGRAVATED
472 reports
9
COUGH
468 reports
10
INFECTION
468 reports