Drug recall D-0609-2018

Class II Terminated reported Apr 4, 2018

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

Reason for recall

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

Lots and codes

Lot # 00538529

Recall details

Recalling firm
Bracco Diagnostics Inc., Monroe Township, NJ
Quantity
2,136 tubes
Distribution
Product was distributed throughout the United States, Hong Kong and New Zealand.
Type
Voluntary: Firm initiated
Recall initiated
March 8, 2018
Terminated
March 1, 2019

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