← FDA ENFORCEMENT
D-0014-2025Class II
Fresenius Kabi Compounding, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Fresenius Kabi Compounding, LLC
Product type
Drug
Status
Terminated
Report date
2024-10-30
Distribution
Product was distributed to 125 direct accounts nationwide.
Firm state
MA
Product quantity
1313 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP violations
Product description
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
Code / lot info
Lot# C274-000039006, exp. date 19-Jan-25
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →