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| The United States: Exela Pharma Sciences, LLC issues voluntary nationwide recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 ml vial, 20-count carton due to vial breakage (English only) |
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The US Food and Drug Administration (FDA) announces that Exela Pharma Sciences, LLC is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 ml vial, 20- count carton, to the consumer level. The vials are labeled with Exela brand and Civica brand. For details of the affected lot numbers, please refer to the website in FDA.
The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Oct 14, 2022
Issued at HKT 14:00
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