Multi-event September 2024 FDA Recall Drug by Fresenius Kabi Compounding, Llc

This Multi-event Class II drug recall was voluntarily initiated by Fresenius Kabi Compounding, Llc on September 25, 2024 for the product Drug. The FDA reported the reason for recall as cgmp violations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0016-2025 TERMINATED D-0020-2025 TERMINATED D-0021-2025 TERMINATED D-0019-2025 TERMINATED D-0014-2025 TERMINATED D-0018-2025 TERMINATED D-0015-2025 TERMINATED D-0023-2025 TERMINATED D-0022-2025 TERMINATED D-0017-2025 TERMINATED

Recall Number: D-0016-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
2756 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# C274-000037039, exp. date 9-Oct-24 C274-000037239, exp. date 21-Oct-24

Recall Number: D-0020-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
733 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

Batch or Lot Expiration Information

Lot# C274-000038404, exp. date 18-Nov-24

Recall Number: D-0021-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
4436 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Batch or Lot Expiration Information

Lot# C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24

Recall Number: D-0019-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
2151 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

Batch or Lot Expiration Information

Lot# C274-000038582, exp. date 29-Nov-24

Recall Number: D-0014-2025

Reason for Recall
CGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
1313 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# C274-000039006, exp. date 19-Jan-25

Recall Number: D-0018-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
1082 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

Batch or Lot Expiration Information

Lot# C274-000038004, exp. date 27-Nov-24

Recall Number: D-0015-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
1631 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Recall Number: D-0023-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
1008 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Batch or Lot Expiration Information

Lot# C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25

Recall Number: D-0022-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
753 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

Batch or Lot Expiration Information

Lot# C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24

Recall Number: D-0017-2025

Reason for Recall
cGMP violations
Initiated
09-25-2024
Reported
10-30-2024
Quantity
1378 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95427
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 125 direct accounts nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Batch or Lot Expiration Information

Lot# C274-000038499, exp. date 21-Dec-24