Drug injection product recalled due to manufacturing quality violations
Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is based on manufacturing process violations rather than confirmed product contamination or defects.
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling one lot of Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL) supplied in single-dose bags. The affected lot is C274-000039006 with an expiration date of January 19, 2025. Approximately 1,313 bags were involved.
The recall was voluntarily initiated by the manufacturer due to violations of Current Good Manufacturing Practice (CGMP). CGMP violations indicate that the manufacturing process did not meet FDA's standards for quality control and safety.
The recalled product was distributed to 125 direct healthcare accounts nationwide.
The recalled product
- Product
- Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable
- Hazard
- manufacturing-quality-concern
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# C274-000039006
- exp. date 19-Jan-25
Distribution
Distributed nationwide across the United States.
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