Drug 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
D-1421-2012
Product summary
- Event
- Event 61714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63,750 ampules
- Official record key
drug-enforcement:D-1421-2012
Official wording
Reason: Presence of Particulate Matter
Code information: Lot #1395 Exp: July 2012
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter