March 2018 FDA Recall E-z-paste by Bracco Diagnostics Inc.
D-0609-2018 - Failed stability specifications

This Class II drug recall was voluntarily initiated by Bracco Diagnostics Inc. on March 8, 2018 for the product E-z-paste. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Product was distributed throughout the United States, Hong Kong and New Zealand. and the recall is currently terminated.

Recall Number: D-0609-2018

Reason for Recall
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Initiated
03-08-2018
Reported
04-04-2018
Quantity
2,136 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79481
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bracco Diagnostics Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States, Hong Kong and New Zealand.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-01-2019
Product Description About Product Description
Full technical description of the product.
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

32909-770-01 E-z-paste