Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Summary
The FDA issued a Class II for Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single D by Fresenius Kabi Compounding, LLC. Reason: cGMP violations.
Details
Source
Drug Recall
External ID
D-0016-2025
Action Date
2024-10-30
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24
Quantity Affected: 2756 bags
Reason for Recall
cGMP violations
Distribution
Product was distributed to 125 direct accounts nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-25
Company
Canton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 37 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi Compounding, LLC has 15 FDA actions in our database, including 15 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi Compounding, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi Compounding, LLC have FDA actions?
Fresenius Kabi Compounding, LLC has 15 FDA actions in our database, including 15 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0016-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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