Phenylephrine HCl 0.9% Sodium Chloride Injection USP recall
FDA recall D-0017-2025 · initiated Sep 25, 2024
Fresenius Kabi Compounding, LLC recalled Phenylephrine HCl 0.9% Sodium Chloride Injection USP in Sep 2024 — an FDA Class II recall (D-0017-2025) because cGMP violations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP violations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1378 bags
Details
- Product
- 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
- Recalling company
- Fresenius Kabi Compounding, LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Initiated
- Sep 25, 2024
- FDA report date
- Oct 30, 2024
Frequently asked
- Was Phenylephrine HCl 0.9% Sodium Chloride Injection USP recalled?
- Fresenius Kabi Compounding, LLC recalled Phenylephrine HCl 0.9% Sodium Chloride Injection USP in Sep 2024 — an FDA Class II recall (D-0017-2025) because cGMP violations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phenylephrine HCl 0.9% Sodium Chloride Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0017-2025 was: cGMP violations
- Is a recalled Phenylephrine HCl 0.9% Sodium Chloride Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenylephrine HCl 0.9% Sodium Chloride Injection USP are affected?
- Distributed: Product was distributed to 125 direct accounts nationwide.. The recall covers these lots — Lot # C274-000038499, exp. date 21-Dec-24. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0017-2025.