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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Exela Pharma Sciences LLC 2023-11-29 Health critical FDA
Health · FDA · Recall #FDA-D-0118-2024

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single… Recall

Issued November 29, 2023 · Exela Pharma Sciences LLC

In November 2023, Exela Pharma Sciences LLC recalled the ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Presence of Particulate Matter: Silicone

What you should do

  1. 1 Stop using ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single… 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
November 29, 2023
Units affected
Not reported
Sold at
Nationwide
Recall number
FDA-D-0118-2024
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 903rd Health recall we've logged in 2023.
Read the official FDA notice

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