FDA recall D-1421-2012

Product

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-04-24

Report date

2012-07-25

Termination date

2017-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shirley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1421-2012