Drug Enforcement D-0016-2025

cGMP violations

Status

Terminated

Classification

Class II

Report Date

October 30, 2024

Termination Date

August 15, 2025

Product Information

Product description
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
Product quantity
2756 bags
Reason for recall
cGMP violations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to 125 direct accounts nationwide.

Location & Firm

Recalling firm
Fresenius Kabi Compounding, LLC
Address
20 Dan Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0016-2025
Event ID
95427
Recall initiation date
September 25, 2024
Center classification date
October 21, 2024
Code info
Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
More code info
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