Medications & Supplements/Prescription Drugs

Bracco Diagnostics Inc.: E-Z-Paste Barium Sulfate Cream Recalled for Preservative Stability Issue

Agency Publication Date: March 29, 2018

Summary

Bracco Diagnostics Inc. is recalling 2,136 tubes of E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w). The recall was initiated because the product failed stability testing due to an out-of-specification result for methylparaben, which is used as a preservative. This affects the 454 g (16 oz) tubes of the esophageal cream distributed across the United States, Hong Kong, and New Zealand. Consumers should contact their healthcare provider or pharmacist regarding any unused product from the affected lot.

Risk

A lower-than-intended level of the preservative methylparaben may reduce the product's ability to prevent microbial growth over its shelf life, potentially leading to contamination or reduced effectiveness.

What You Should Do

Check your medical supplies for E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) in 454 g tubes with NDC number 32909-770-01.
Locate the lot number on the tube or packaging and verify if it matches affected lot # 00538529.
If you have a tube from the affected lot, contact your healthcare provider or pharmacist for guidance on how to proceed and to report any concerns.
Return any unused product from the affected lot to your pharmacy for a refund.
Contact Bracco Diagnostics Inc. at their Monroe Township, New Jersey location for further instructions regarding this recall.
For additional questions, contact 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) (454 g tube)

Model:

NDC 32909-770-01

Recall #: D-0609-2018

Lot Numbers:

00538529

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79481

Status: Resolved

Manufacturer: Bracco Diagnostics Inc.

Sold By: authorized distributors; pharmacies; medical providers

Manufactured In: United States, Canada

Units Affected: 2,136 tubes

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 medical supplies for E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) in 454 g tubes with NDC number 32909-770-01.

Locate the lot number on the tube or packaging and verify if it matches affected lot # 00538529.

If you have a tube from the affected lot, contact your healthcare provider or pharmacist for guidance on how to proceed and to report any concerns.

Return any unused product from the affected lot to your pharmacy for a refund.

Contact Bracco Diagnostics Inc. at their Monroe Township, New Jersey location for further instructions regarding this recall.

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