Metoclopramide Injection, Solution
FDA Recall NDC 0703-4502

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Metoclopramide (NDC 0703-4502). A significant event, classified as Class II, was initiated on Jul 29, 2021 by Teva Parenteral Medicines, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"

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

D-0741-2021TERMINATEDD-0377-2021TERMINATEDD-0297-2021TERMINATEDD-0277-2021TERMINATED

July 2021 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0741-2021
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jul 29, 2021
Reported
Aug 25, 2021
Quantity
25,653 vials

Recall Profile & Regulatory Data

Event ID
88442
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
Termination Date
Jun 04, 2024
Product Description
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01
Batch or Lot Expiration Information
Lot# : 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023
Affected Packages Involved in this Recall
0703-4502-01Product
0703-4502-04Product

April 2021 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0377-2021
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility
Initiated
Apr 26, 2021
Reported
May 26, 2021
Quantity
3,138/25 single use vials per tray

Recall Profile & Regulatory Data

Event ID
87875
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Jun 04, 2024
Product Description
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
Batch or Lot Expiration Information
Lot# 31325459B, exp. date 08/2021
Affected Packages Involved in this Recall
0703-4502-01Product
0703-4502-04Product

February 2021 Class II Recall: Chemical contamination; Unknown brown residue adhering to the inside of one vial.

Recall Number
D-0297-2021
Class II Terminated
Reason for Recall
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Initiated
Feb 15, 2021
Reported
Mar 10, 2021
Quantity
9,452 cartons

Recall Profile & Regulatory Data

Event ID
87330
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, including Puerto Rico
Termination Date
Aug 26, 2021
Product Description
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
Batch or Lot Expiration Information
Lot# 31325335B, exp. date 07/2021
Affected Packages Involved in this Recall
0703-4502-01Product
0703-4502-04Product

February 2021 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0277-2021
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Initiated
Feb 10, 2021
Reported
Mar 03, 2021
Quantity
29,357 vials

Recall Profile & Regulatory Data

Event ID
87298
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Termination Date
May 15, 2024
Product Description
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
Batch or Lot Expiration Information
Lot# 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021
Affected Packages Involved in this Recall
0703-4502-01Product
0703-4502-04Product

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.