FDAHealthSeptember 25, 2024
Fresenius Kabi Compounding, LLC — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
⚠️ cGMP violations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 25, 2024
Product was distributed to 125 direct accounts nationwide.
What's affected?
- 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 71506-010-58
- Lot code
- C274-000037039
Additional details
Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2756 bags.
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