Medicine recalls
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| The United States: Enforcement Report: Recall of E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454g tube |
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The US Food and Drug Administration (FDA) announces that Bracco Diagnostics Inc. is recalling one lot (lot number: 00538529) of E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454g tube, manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883. The reason for recall is failed stability specifications: out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Please refer to the following website in FDA for details:
http://www.accessdata.fda.gov/../index.cfm?Product=162435
In Hong Kong, E-Z-Paste 60% W/W (Barium Sulfate Esophageal Cream) (HK-19221) is a pharmaceutical product registered by A R Burkill & Sons (HK) Ltd. According to the company, a total of 108 tubes of the affected batch were imported in 2016 and 2017 and were all supplied to the Hospital Authority. The Department of Health (DH) endorsed A R Burkill & Sons (HK) Ltd to recall the affected batch from the market. The company was also instructed to seek investigation report from the manufacturer in Canada. The product, containing barium sulphate, is a medicine used for single contrast radiography of the esophagus. DH will closely monitor the recall. So far, the DH has not received any adverse reaction reports in connection with the affected batch of product.
Ends/Wednesday, Apr 4, 2018
Issued at HKT 17:30
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