← FDA ENFORCEMENT
D-0015-2025Class 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
1631 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason 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 71506-024-58

Code / lot info

Lot # C274-000037046, exp. date 13-Oct-24

Other recalls SPEQ maps to Risk Management & CAPA
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 →