Naloxone Hydrochloride Injection, Solution
FDA Recall NDC 0409-1782
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Naloxone Hydrochloride (NDC 0409-1782). A significant event, classified as Class I, was initiated on Jun 04, 2018 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter; Potential for particulate matter on the syringe plunger."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
June 2018 Class I Recall: Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Recall Number
Class I Terminated
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Jun 04, 2018
Jun 13, 2018
164,860 syringes
Recall Profile & Regulatory Data
Event ID
80167
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
HOSPIRA INC, LAKE FOREST
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S., Puerto Rico, and Guam
Termination Date
Mar 27, 2020
Product Description
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
Batch or Lot Expiration Information
Lot# 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Affected Packages Involved in this Recall
0409-1782-03Product
0409-1782-69Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
