Buprenorphine Hydrochloride Injection, Solution
FDA Recall NDC 0409-2012
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Buprenorphine Hydrochloride (NDC 0409-2012). A significant event, classified as Class II, was initiated on May 20, 2024 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility-The potential for incomplete crimp seals."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
May 2024 Class II Recall: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall Number
Class II Ongoing
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
May 20, 2024
Jul 03, 2024
84,710 cartridges
Recall Profile & Regulatory Data
Event ID
94681
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide and Puerto Rico.
Product Description
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
Batch or Lot Expiration Information
Lot# : HJ3965; Exp 2024/09
Lot# : HJ8546; Exp 2024/10
Affected Packages Involved in this Recall
0409-2012-03Product
0409-2012-32Product
September 2014 Class II Recall: Failed Impurities/Degradation Specification
Recall Number
Class II Terminated
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Sep 09, 2014
Oct 01, 2014
373,180 Carpuject units
Recall Profile & Regulatory Data
Event ID
69163
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 17, 2017
Product Description
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
Batch or Lot Expiration Information
Lot# Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
Affected Packages Involved in this Recall
0409-2012-03Product
0409-2012-32Product
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.
