Medications & Supplements/Prescription Drugs

Fresenius Kabi Compounding Injectable Medications Recalled for CGMP Violations

Agency Publication Date: October 21, 2024

Summary

Fresenius Kabi Compounding, LLC is recalling 17,241 bags of various injectable medications, including Phenylephrine HCl, Vancomycin HCl, Norepinephrine Bitartrate, Oxytocin, Epinephrine, and Thiamine HCl. The recall was initiated because the products were manufactured under conditions that violated Current Good Manufacturing Practice (CGMP) standards. These quality control regulations ensure that drugs are safe, pure, and have the correct strength and ingredients.

Risk

Violations of manufacturing standards can result in medications that are contaminated or have incorrect dosages. While no injuries have been reported, using drugs that do not meet these quality standards can lead to ineffective treatment or serious clinical complications during medical procedures.

What You Should Do

This recall affects various injectable medications in single-dose bags, including Phenylephrine, Vancomycin, Norepinephrine, Oxytocin, Epinephrine, and Thiamine produced by Fresenius Kabi Compounding (also labeled as Fagron Sterile Services).
Identify if you have affected stock by checking the drug name, NDC number, and lot number on the bag or carton label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled products immediately. Contact Fresenius Kabi Compounding or your distributor to arrange for the return of any remaining stock.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000039006 (Exp 19-Jan-25)

NDC:

71506-002-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0014-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037046 (Exp 13-Oct-24)

NDC:

71506-024-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0015-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (10 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037039 (Exp 9-Oct-24)

C274-000037239 (Exp 21-Oct-24)

NDC:

71506-010-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0016-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (10 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038499 (Exp 21-Dec-24)

NDC:

71506-029-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0017-2025

Product: Vancomycin HCl 0.9% Sodium Chloride Injection USP (750 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038004 (Exp 27-Nov-24)

NDC:

71506-014-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0018-2025

Product: Norepinephrine Bitartrate 0.9% Sodium Chloride Injection USP (4 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038582 (Exp 29-Nov-24)

NDC:

71506-025-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0019-2025

Product: Norepinephrine Bitartrate 0.9% Sodium Chloride Injection USP (8 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038404 (Exp 18-Nov-24)

NDC:

71506-027-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0020-2025

Product: Oxytocin 0.9% Sodium Chloride Injection USP (30 units per 500 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038801 (Exp 9-Oct-24)

C274-000039045 (Exp 24-Oct-24)

C274-000039240 (Exp 31-Oct-24)

NDC:

71506-028-59

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0021-2025

Product: Epinephrine 0.9% Sodium Chloride Injection USP (8 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038958 (Exp 17-Oct-24)

C274-000039206 (Exp 23-Oct-24)

NDC:

71506-060-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0022-2025

Product: Thiamine HCl 0.9% Sodium Chloride Injection USP (500 mg per 100 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037436 (Exp 30-Oct-24)

C274-000038893 (Exp 7-Jan-25)

NDC:

71506-079-56

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0023-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95427

Status: Resolved

Manufacturer: Fresenius Kabi Compounding, LLC

Sold By: Hospital direct accounts; Medical distributors

Manufactured In: United States

Units Affected: 10 products (1313 bags; 1631 bags; 2756 bags; 1378 bags; 1082 bags; 2151 bags; 733 bags; 4436 bags; 753 bags; 1008 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various injectable medications in single-dose bags, including Phenylephrine, Vancomycin, Norepinephrine, Oxytocin, Epinephrine, and Thiamine produced by Fresenius Kabi Compounding (also labeled as Fagron Sterile Services).

Identify if you have affected stock by checking the drug name, NDC number, and lot number on the bag or carton label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled products immediately. Contact Fresenius Kabi Compounding or your distributor to arrange for the return of any remaining stock.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Affected Products

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000039006 (Exp 19-Jan-25)

NDC:

71506-002-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0014-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (20 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037046 (Exp 13-Oct-24)

NDC:

71506-024-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0015-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (10 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037039 (Exp 9-Oct-24)

C274-000037239 (Exp 21-Oct-24)

NDC:

71506-010-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0016-2025

Product: Phenylephrine HCl 0.9% Sodium Chloride Injection USP (10 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038499 (Exp 21-Dec-24)

NDC:

71506-029-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0017-2025

Product: Vancomycin HCl 0.9% Sodium Chloride Injection USP (750 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038004 (Exp 27-Nov-24)

NDC:

71506-014-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0018-2025

Product: Norepinephrine Bitartrate 0.9% Sodium Chloride Injection USP (4 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038582 (Exp 29-Nov-24)

NDC:

71506-025-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0019-2025

Product: Norepinephrine Bitartrate 0.9% Sodium Chloride Injection USP (8 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038404 (Exp 18-Nov-24)

NDC:

71506-027-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0020-2025

Product: Oxytocin 0.9% Sodium Chloride Injection USP (30 units per 500 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038801 (Exp 9-Oct-24)

C274-000039045 (Exp 24-Oct-24)

C274-000039240 (Exp 31-Oct-24)

NDC:

71506-028-59

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0021-2025

Product: Epinephrine 0.9% Sodium Chloride Injection USP (8 mg per 250 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000038958 (Exp 17-Oct-24)

C274-000039206 (Exp 23-Oct-24)

NDC:

71506-060-58

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0022-2025

Product: Thiamine HCl 0.9% Sodium Chloride Injection USP (500 mg per 100 mL)

Variants: Single Dose Bag, Rx only

Lot Numbers:

C274-000037436 (Exp 30-Oct-24)

C274-000038893 (Exp 7-Jan-25)

NDC:

71506-079-56

Labeled for Fagron Sterile Services, Canton, MA; Recall #: D-0023-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95427

Status: Resolved

Manufacturer: Fresenius Kabi Compounding, LLC

Sold By: Hospital direct accounts; Medical distributors

Manufactured In: United States

Units Affected: 10 products (1313 bags; 1631 bags; 2756 bags; 1378 bags; 1082 bags; 2151 bags; 733 bags; 4436 bags; 753 bags; 1008 bags)

Distributed To: Nationwide