HYDROCORTISONE AND ACETIC ACID
Generic: HYDROCORTISONE AND ACETIC ACID OTIC
Saptalis PharmaceuticalsManufacturer
AURICULAR (OTIC)Route
ACETIC ACIDActive Substance
1961-06-23Original Approval
HYDROCORTISONE AND ACETIC ACID is FDA application NDA012770, sponsored by SAPTALIS PHARMS. 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 II2017-12-15
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 Presence of Particulate Matter: identified as polyethylene, which is consistent with the material us
Class III2023-11-06
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc.Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related
Top Reported Reactions
1
NAUSEA
38 reports
2
DIARRHOEA
29 reports
3
TOXICITY TO VARIOUS AGENTS
29 reports
4
PAIN
27 reports
5
COUGH
25 reports
6
DYSPNOEA
25 reports
7
DRUG INEFFECTIVE
23 reports
8
ARTHRALGIA
21 reports
9
CORONARY ARTERY DISEASE
21 reports
10
OFF LABEL USE
21 reports