Drug recall: Sodium Bicarbonate Injection recalled due to this reason

The product is used for the treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton.

374
Drug recall
Drug recall

Last Updated on October 15, 2024 by The Health Master

FOR IMMEDIATE RELEASE – Exela Pharma Sciences, LLC, (Exela) is expanding its recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton.

Risk Statement: 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 the skin, eyes, and/or other parts which could result in either temporary or permanent injury.

Within the sixty-three (63) total recalled lots (which include more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring the skin, eyes, and/or other parts.

There have been no complaints of vial breakage or injuries related to the additional fourteen (14) lots. There have been no reports of sterility failures to date with any of the sixty-three (63) lots.

The product is used for the treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton.

The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

Drug recall: Dr Reddy’s, Sun Pharma recall these drugs due to this reason

Drug recall: FDA issues nationwide recall for Ferric Carboxymaltose

Drug recall: These drugs recalled by Aurobindo for this reason

Drug recall: These products recalled by Dr Reddy’s, Cipla, and Aurobindo

Drug recall: Sodium Bicarbonate Injection recalled due to this reason

Drug recall: Acyclovir Sodium Injection recalled due to this reason

USFDA-Gujarat FDCA to meet to discuss GMP compliance, capacity building

CDSCO panel gives nod for Esomeprazole Dual Release Gastro resistant tablets

Drug recall: Dr. Reddy’s, Sun Pharma recall these drugs due to this reason

USFDA gives nod for Diclofenac Sodium topical solution

IPC releases amendment list for IP 2022, details here

NPPA releases 2nd list with draft ceiling prices for 43 formulations

USFDA gives approval for Venlafaxine ER tablets

Gujarat FDCA launches online licensing system for cosmetics

IPC to digitize Indian Pharmacopoeia (IP) soon

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news