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Class II: temporary or reversible health riskTerminated

Luitpold Pharmaceuticals Epinephrine Injection Recall

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For…

Luitpold Pharmaceuticals, Inc. · Shirley, NY

Risk level
Class II
Reported by FDA
Jul 25, 2012
Recall ID
D-1421-2012
Check your lot numberHow we source this data

Summary

Luitpold Pharmaceuticals recalled Epinephrine Injection starting Apr 24, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1421-2012 on Jul 25, 2012. Reason: Presence of Particulate Matter. Status: Terminated.

Why it was recalled

Presence of Particulate Matter

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

Lot numbers, UPCs & expiration codes

Lot #1395 Exp: July 2012

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1421-2012
Classification
Class II
Status
Terminated
Recall initiated
Apr 24, 2012
FDA report date
Jul 25, 2012
Quantity
63,750 ampules
Recall type
Voluntary: Firm initiated
Recalling firm
Luitpold Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1421-2012, exactly as published.

Show all FDA fields
City
Shirley
State
NY
Status
Terminated
Country
United States
Event ID
61714
Address
One Luitpold Drive
Address (line 2)
P.O. Box 9001
Code information
Lot #1395 Exp: July 2012
Postal code
11967-9001
Report date
Jul 25, 2012
Product type
Drugs
Recall number
D-1421-2012
Classification
Class II
Recalling firm
Luitpold Pharmaceuticals, Inc.
Product quantity
63,750 ampules
Termination date
Apr 11, 2017
Reason for recall
Presence of Particulate Matter
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Apr 24, 2012
Initial firm notification
Letter
Center classification date
Jul 16, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1421-2012, published Jul 25, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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