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

FDA recall notice · announced July 25, 2012 · Luitpold Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot #1395 Exp: July 2012
Quantity: 63,750 ampules
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.