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Serious recall: Injury is possible or has been reported. Take action promptly.

Exela Pharma Sciences LLC 2022-01-19 Health serious FDA
Health · FDA · Recall #FDA-D-0369-2022

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only,… Recall

Issued January 19, 2022 · Exela Pharma Sciences LLC

In January 2022, Exela Pharma Sciences LLC recalled the 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Lack of Assurance of Sterility

What you should do

  1. 1 Stop using 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Exela Pharma Sciences LLC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Exela Pharma Sciences LLC
Category
Health
Recall date
January 19, 2022
Units affected
Not reported
Sold at
Nationwide within the United States
Recall number
FDA-D-0369-2022
Made in
United States
Issuing agency
FDA

In context

  • Exela Pharma Sciences LLC has 5 recalls in our database, including 3 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 870th Health recall we've logged in 2022.
Read the official FDA notice

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