Status
Terminated
Drug Enforcement D-1421-2012
Presence of Particulate Matter
Classification
Class II
Report Date
July 25, 2012
Termination Date
April 11, 2017
Product Information
- Product description
- 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
- Product quantity
- 63,750 ampules
- Reason for recall
- Presence of Particulate Matter
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Luitpold Pharmaceuticals, Inc.
- Address
-
One Luitpold Drive, P.O. Box 9001
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1421-2012
- Event ID
- 61714
- Recall initiation date
- April 24, 2012
- Center classification date
- July 16, 2012
- Code info
- Lot #1395 Exp: July 2012
- More code info
- —