Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Metoclopramide Injection Recalled for Unknown Chemical Contamination

Agency Publication Date: March 3, 2021

Summary

Teva Pharmaceuticals has recalled 9,452 cartons of Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), a medication used to treat certain stomach and esophageal problems. The recall was initiated because an unknown brown residue was found adhering to the inside of one vial during inspection. This contamination indicates a quality defect that could pose a health risk if the medication is administered. This product was distributed nationwide across the United States and Puerto Rico.

Risk

The presence of unknown chemical residue inside a sterile injectable vial could result in the administration of contaminated medication, potentially leading to adverse reactions, infections, or other localized or systemic health complications.

What You Should Do

Check your medicine supply for Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), specifically 25x2mL Single Dose Vials.
Verify if your product belongs to Lot # 31325335B with an expiration date of 07/2021. You can find these details on the vial label (NDC 0703-4502-01) or the outer tray (NDC 0703-4502-04).
Immediately stop using any vials from the affected lot and set them aside to ensure they are not administered.
Contact your healthcare provider or pharmacist immediately to discuss alternative medications and to report if you have experienced any health problems related to this product.
Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.
Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054-1120) or through your pharmacist for further instructions on how to return the product.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmaceutical refund and guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials

Model:

NDC 0703-4502-01 (vial)

NDC 0703-4502-04 (tray)

Lot Numbers:

31325335B (Exp 07/2021)

Date Ranges: 07/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87330

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Manufactured In: United States

Units Affected: 9,452 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine supply for Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), specifically 25x2mL Single Dose Vials.

Verify if your product belongs to Lot # 31325335B with an expiration date of 07/2021. You can find these details on the vial label (NDC 0703-4502-01) or the outer tray (NDC 0703-4502-04).

Immediately stop using any vials from the affected lot and set them aside to ensure they are not administered.

Contact your healthcare provider or pharmacist immediately to discuss alternative medications and to report if you have experienced any health problems related to this product.

Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.

Contact Teva Pharmaceuticals USA at their distributor address (400 Interpace Pkwy, Parsippany, NJ 07054-1120) or through your pharmacist for further instructions on how to return the product.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.