Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. The hazard is theoretical—potential compromise of manufacturing standards for an injectable medication. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling 1,378 bags of Phenylephrine HCl 0.9% Sodium Chloride Injection USP (10 mg per 250 mL, single dose bags) due to current good manufacturing practice (cGMP) violations. The affected product is Lot # C274-000038499, with an expiration date of December 21, 2024. This is a Class II recall, indicating a serious health consequence or death is possible, though no illnesses or injuries have been reported.
The recall was initiated due to violations of current good manufacturing practices in the production of this injectable medication. Manufacturing practice violations could potentially compromise the sterility, purity, or potency of the product.
The product was distributed to 125 direct healthcare accounts nationwide. This is a voluntary recall initiated by the manufacturer on September 25, 2024. The FDA classified this recall on October 21, 2024.
The recalled product
- 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
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- cgmp-violation
- sterility-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # C274-000038499
- exp. date 21-Dec-24
Distribution
Distributed nationwide across the United States.
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