Sodium Chloride Injection, Solution
FDA Recall NDC 0409-4888
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 Sodium Chloride (NDC 0409-4888). A significant event, classified as Class II, was initiated on Jun 27, 2013 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial."
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
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Jun 27, 2013
Jul 31, 2013
268,700 vials
Recall Profile & Regulatory Data
Event ID
65731
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Guam
Termination Date
Jun 04, 2015
Product Description
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
Batch or Lot Expiration Information
Lot# : 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Affected Packages Involved in this Recall
0409-4888-02Product
0409-4888-10Product
0409-4888-03Product
0409-4888-20Product
0409-4888-06Product
0409-4888-50Product
0409-4888-01Product
0409-4888-12Product
0409-4888-90Product
0409-1918-42Product
0409-1918-32Product
0409-1918-43Product
0409-1918-33Product
0409-1918-45Product
0409-1918-35Product
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.
