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| The United States: Exela Pharma Sciences, LLC expands 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 expanding its recall, adding 14 lots to the ongoing voluntary recall of 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 ml vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. For details of the affected lot numbers, please refer to the website in FDA. The vials are labeled with Exela brand and Civica brand.
The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the 63 total recalled lots (which includes more than 2.7 million vials), Exela has received 5 reports of flying glass injuring skin, eye and/or other parts. There have been no complaints of vial breakage or injuries related to the additional 14 lots. There have been no reports of sterility failures to date with any of the 63 lots.
Exela did not recall the additional 14 lots previously because they did not appear to be impacted. During the latest inspection of Exela’s retain product from the 14 lots, one vial showed breakage. There have been no field reports of personal injury to date across all the 63 lots since the recall process started. However, out of an abundance of caution, Exela is adding the 14 lots to the on-going recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 14 Oct 2022.
Ends/Wednesday, Nov 30, 2022
Issued at HKT 16:00
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