FDAClass IIJuly 25, 2012

Epinephrine Injection recall: Particulate Matter

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.…

Why was Epinephrine Injection recalled?

Presence of Particulate Matter

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #1395 Exp: July 2012

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.…
Recalling firm
Luitpold Pharmaceuticals, Inc.
Quantity
63,750 ampules
Distribution
Nationwide
Recall date
July 25, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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