CLASS II Drug recall · Reported 30 Oct 2024 · FDA Enforcement Report
Phenylephrine HCl 0.9% Sodium Chloride Injection recalled
Fresenius Kabi Compounding is recalling Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per, Single Dose, distributed nationwide in the US. The recall was initiated on 25 Sep 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0017-2025
- FDA event ID
- 95427
- Recalling firm
- Fresenius Kabi Compounding, Canton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2024
- FDA classified
- 21 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 25 Sep 2024 | Recall initiated by company | |
| 21 Oct 2024 | Classified by FDA | +26 days |
| 30 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP violations
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 125 direct accounts nationwide.
Questions about this recall
Why was it recalled?
cGMP violations
Which lots are affected?
Lot # C274-000038499, exp. date 21-Dec-24
Where was it sold?
Product was distributed to 125 direct accounts nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 95427This product is part of a recall event; the main page for the event is NORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalled.
More recalls from Fresenius Kabi Compounding
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | acyclovir sodium, 200 mg, 200mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
Other Phenylephrine Chloride recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCl 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Phenylephrine HCl 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Phenylephrine HCl 0.9% Sodium Chloride Injection recalled | Fresenius Kabi Compounding | Manufacturing (CGMP) Deviations | Nationwide |