Quelicin Injection, Solution
FDA Recall NDC 0409-6629
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Quelicin (NDC 0409-6629). A significant event, classified as Class II, was initiated on Jun 15, 2017 by Hospira, Inc.. The reported reason for this action was: "Lack of Sterility Assurance"
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
Class II Terminated
Lack of Sterility Assurance
Jun 15, 2017
Aug 09, 2017
15,034,600 10 mL multiple dose use vials
Recall Profile & Regulatory Data
Event ID
77533
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira a Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Termination Date
Jul 20, 2020
Product Description
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).
Batch or Lot Expiration Information
Lot# a.) one vial Lot: 74393EV Exp. 05/01/2018 Lot: 75157EV Exp. 06/01/2018 Lot: 75367EV, Exp. 06/01/2018 b.) 25 vial carton Lot: 75158EV; Exp. 06/01/2018
Affected Packages Involved in this Recall
0409-6629-12Product
0409-6629-02Product
0409-6970-10Product
0409-6629-25Product
Class III Ongoing
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Mar 15, 2016
May 11, 2016
103,600 vials
Recall Profile & Regulatory Data
Event ID
73647
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
Batch or Lot Expiration Information
Lot# Lot 52-045-EV, Exp 07/1/2016
Affected Packages Involved in this Recall
0409-6629-12Product
0409-6629-02Product
0409-6970-10Product
Class II Terminated
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Feb 26, 2013
May 15, 2013
139,200 vials
Recall Profile & Regulatory Data
Event ID
65077
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 10, 2014
Product Description
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02
Batch or Lot Expiration Information
Lot# Lot 21-480-EV Exp.12/13
Affected Packages Involved in this Recall
0409-6629-12Product
0409-6629-02Product
0409-6970-10Product
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.
