OMEGA-3-ACID ETHYL ESTERS

Generic: OMEGA-3-ACID ETHYL ESTERS

EPIC PHARMAManufacturer
ORALRoute
OMEGA-3-ACID ETHYL ESTERSActive Substance
2020-06-15Original Approval

OMEGA-3-ACID ETHYL ESTERS is FDA application ANDA210093, sponsored by PURACAP PHARM LLC. 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 II2026-04-09
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac

Failed Capsule Specifications: Out of specification results obtained during routine stability testin

Top Reported Reactions

1
PRODUCT ODOUR ABNORMAL
93 reports
2
CHEST PAIN
81 reports
3
DIARRHOEA
68 reports
4
NAUSEA
64 reports
5
OFF LABEL USE
64 reports
6
DRUG INEFFECTIVE
63 reports
7
MALAISE
59 reports
8
PAIN
56 reports
9
POOR QUALITY PRODUCT ADMINISTERED
50 reports
10
DYSPNOEA
49 reports