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Moderate recall: A hazard has been identified, with no injuries reported yet. Follow the steps below.

Hikma Injectables USA Inc 2024-05-08 Health moderate FDA
Health · FDA · Recall #FDA-D-0480-2024

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL… Recall

Issued May 8, 2024 · Hikma Injectables USA Inc

In May 2024, Hikma Injectables USA Inc recalled the Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL…, a moderate health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Labeling: Wrong Barcode

What you should do

  1. 1 Stop using Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Hikma Injectables USA Inc 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
Hikma Injectables USA Inc
Category
Health
Recall date
May 8, 2024
Units affected
Not reported
Sold at
Nationwide within the United States
Recall number
FDA-D-0480-2024
Made in
United States
Issuing agency
FDA

In context

  • Hikma Injectables USA Inc has 2 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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