# FDA recall D-1421-2012

> **Luitpold Pharmaceuticals, Inc.** · Class II · drug recall initiated 2012-04-24.

## 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

- **Recall number:** D-1421-2012
- **Recalling firm:** Luitpold Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1421-2012. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1421-2012. Source: US FDA. Licensed CC0.

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