Metoclopramide Injection, Solution
FDA Recall NDC 0409-3414
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 Metoclopramide (NDC 0409-3414). A significant event, classified as Class II, was initiated on Sep 24, 2013 by Hospira, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials."
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: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Sep 24, 2013
Nov 27, 2013
251,400 vials
Recall Profile & Regulatory Data
Event ID
66422
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Oct 06, 2014
Product Description
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
Batch or Lot Expiration Information
Lot# : 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Affected Packages Involved in this Recall
0409-3414-18Product
0409-3414-01Product
0409-3414-21Product
0409-3414-11Product
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.
