E-z-paste Cream
FDA Recall NDC 32909-770
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 E-z-paste (NDC 32909-770). A significant event, classified as Class II, was initiated on Mar 08, 2018 by E-z-em Canada Inc. The reported reason for this action was: "Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot."
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
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Mar 08, 2018
Apr 04, 2018
2,136 tubes
Recall Profile & Regulatory Data
Event ID
79481
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bracco Diagnostics Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States, Hong Kong and New Zealand.
Termination Date
Mar 01, 2019
Product Description
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Batch or Lot Expiration Information
Lot# 00538529
Affected Packages Involved in this Recall
32909-770-01Product
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.
