The Recall Desk
SevereFDA (Drugs)·D-1421-2012·Announced 2012-07-25

Luitpold Recalls Epinephrine Injection Ampules Due to Particulate Matter

Luitpold Pharmaceuticals is recalling Epinephrine Injection ampules because of the presence of particulate matter. The affected lot was distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports.

Plain-English summary

Luitpold Pharmaceuticals, Inc. is recalling 63,750 ampules of Epinephrine Injection, USP, 1:1000 (1 mg/mL). The product is packaged as 25 x 1 mL ampules intended for subcutaneous and intramuscular use, or intravenous and intracardiac use after dilution. The specific lot number is 1395, with an expiration date of July 2012.

The recall was initiated due to the presence of particulate matter in the product. The affected units were distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

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
Manufacturer
Luitpold Pharmaceuticals, Inc.
Category
Drug — Injection
Hazard
Affected units
63,750

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #1395 Exp: July 2012

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Luitpold Pharmaceuticals, Inc.

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Same hazard · particulate matter

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