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Drug FDA Class II Terminated cGMP deviation

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Fresenius Kabi Compounding, LLC Published Oct 30, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Fresenius Kabi Compounding, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP violations

Affected products (1)

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

1378 bags

Lot codes: C274-000038499
Code info: Lot # C274-000038499, exp. date 21-Dec-24

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 25, 2024
  2. Published
    Oct 30, 2024
  3. Terminated
    Aug 15, 2025
Recall number
D-0017-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.