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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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