Medications & Supplements/Prescription Drugs

Nephron Sterile IV Medications Recalled Due to Lack of Sterility Assurance

Agency Publication Date: February 27, 2023

Summary

Nephron Sterile Compounding Center LLC is recalling 1,638,212 units of various IV medications, including Diltiazem HCl, Norepinephrine Bitartrate, and Phenylephrine HCl. The recall was initiated because the products lack assurance of sterility, meaning they may not be completely free of bacteria or other microorganisms. No injuries or infections have been reported to date. These medications were distributed nationwide to hospitals and clinics through the Nephron 503B Outsourcing Facility.

Risk

Administering a medication intended to be sterile that is actually contaminated can lead to serious, life-threatening infections in patients. While no incidents have been reported, the lack of sterility assurance poses a high risk to patient safety.

What You Should Do

This recall affects various sterile IV medications manufactured by Nephron 503B Outsourcing Facility, including Diltiazem HCl, Norepinephrine Bitartrate, and Phenylephrine HCl in various strengths and sizes.
Check your inventory for NDC codes 69374-997-15, 69374-316-25, 69374-319-25, 69374-315-25, 69374-302-10, 69374-305-10, 69374-301-10, or 69374-321-25. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for 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: Diltiazem HCl in 0.7% Sodium Chloride Injection (125 mg/125 mL)by Nephron 503B Outsourcing Facility

Variants: 1 mg/mL, 125 mL Single-Dose Container bottle

Lot Numbers:

DS2053 (Exp. 2/27/2023)

NDC:

69374-997-15

Packaged in 15 x 1 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (8 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 32 mcg/mL, 250 mL Single-Dose Container

Lot Numbers:

NB2015A (Exp. 02/27/2023)

NB2016A (Exp. 02/19/2023)

NB2021A (Exp. 03/05/2023)

NB2023A (Exp. 03/12/2023)

NB2026A (Exp. 03/29/2023)

NB2029A (Exp. 04/21/2023)

NB2031A (Exp. 04/21/2023)

NB2033A (Exp. 05/10/2023)

NB2034A (Exp. 05/19/2023)

NB2037A (Exp. 05/25/2023)

NB2039A (Exp. 06/05/2023)

NB2041A (Exp. 06/14/2023)

NB2044A (Exp. 06/18/2023)

NB2050A (Exp. 07/19/2023)

NB2054A (Exp. 08/04/2023)

NB2057A (Exp. 08/12/2023)

NB2059A (Exp. 08/20/2023)

NB2061A (Exp. 09/14/2023)

NB2067A (Exp. 09/22/2023)

NDC:

69374-316-25

Packaged in 15 x 1 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (4 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 16 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

NB2017A (Exp. 03/04/2023)

NB2019A (Exp. 02/21/2023)

NB2024A (Exp. 03/27/2023)

NB2025A (Exp. 03/24/2023)

NB2027A (Exp. 04/07/2023)

NB2035A (Exp. 05/22/20123)

NB2038A (Exp. 06/02/2023)

NB2045A (Exp. 06/25/2023)

NB2053A (Exp. 07/29/2023)

NB2058B (Exp. 08/16/2023)

NB2064A (Exp. 09/07/2023)

NB2069A (Exp. 09/25/2023)

NB2071A (Exp. 10/01/2023)

NDC:

69374-319-25

Packaged in 15 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (16 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 64 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

NB2018A (Exp. 02/24/2023)

NB2022A (Exp. 03/08/2023)

NB2028A (Exp. 04/04/2023)

NB2032A (Exp. 04/24/2023)

NB2036A (Exp. 05/24/2023)

NB2043A (Exp. 06/17/2023)

NB2046A (Exp. 06/26/2023)

NB2049A (Exp. 07/21/2023)

NB2052A (Exp. 07/27/2023)

NB2062A (Exp. 09/13/2023)

NB2068A (Exp. 09/23/2023)

NDC:

69374-315-25

Packaged in 15 IV Bottles per carton

Product: Phenylephrine HCl Injection, USP (1 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 100 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2025 (Exp. 05/28/2023)

PE2026 (Exp. 06/02/2023)

PE2027 (Exp. 06/04/2023)

PE2030 (Exp. 06/29/2023)

PE2031 (Exp. 06/27/2023)

PE2032 (Exp. 07/09/2023)

PE2032A (Exp. 07/09/2023)

PE2033 (Exp. 08/03/2023)

PE2034 (Exp. 08/31/2023)

PE2035 (Exp. 09/11/2023)

NDC:

69374-302-10

Packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl Injection, USP (0.4 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 40 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2028 (Exp. 06/15/2023)

NDC:

69374-305-10

Packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl Injection, USP (0.8 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 80 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2029 (Exp. 06/17/2023)

NDC:

69374-301-10

Packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP (50 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 200 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

PS2008A (Exp. 03/07/2023)

NDC:

69374-321-25

Packaged in 15 x 1 IV Bottles per carton

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91749

Status: Resolved

Manufacturer: Nephron Sterile Compounding Center LLC

Sold By: Hospitals; Clinics; Nephron 503B Outsourcing Facility

Manufactured In: United States

Units Affected: 8 products (4,743 bottles; 443,483 bottles; 305,895 bottles; 270,291 bottles; 546,450 vials; 31,500 vials; 24,870 vials; 10,980 bottles)

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 sterile IV medications manufactured by Nephron 503B Outsourcing Facility, including Diltiazem HCl, Norepinephrine Bitartrate, and Phenylephrine HCl in various strengths and sizes.

Check your inventory for NDC codes 69374-997-15, 69374-316-25, 69374-319-25, 69374-315-25, 69374-302-10, 69374-305-10, 69374-301-10, or 69374-321-25. See the Affected Products section below for the full list of affected codes.

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

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Affected Products

Product: Diltiazem HCl in 0.7% Sodium Chloride Injection (125 mg/125 mL)by Nephron 503B Outsourcing Facility

Variants: 1 mg/mL, 125 mL Single-Dose Container bottle

Lot Numbers:

DS2053 (Exp. 2/27/2023)

NDC:

69374-997-15

Packaged in 15 x 1 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (8 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 32 mcg/mL, 250 mL Single-Dose Container

Lot Numbers:

NB2015A (Exp. 02/27/2023)

NB2016A (Exp. 02/19/2023)

NB2021A (Exp. 03/05/2023)

NB2023A (Exp. 03/12/2023)

NB2026A (Exp. 03/29/2023)

NB2029A (Exp. 04/21/2023)

NB2031A (Exp. 04/21/2023)

NB2033A (Exp. 05/10/2023)

NB2034A (Exp. 05/19/2023)

NB2037A (Exp. 05/25/2023)

NB2039A (Exp. 06/05/2023)

NB2041A (Exp. 06/14/2023)

NB2044A (Exp. 06/18/2023)

NB2050A (Exp. 07/19/2023)

NB2054A (Exp. 08/04/2023)

NB2057A (Exp. 08/12/2023)

NB2059A (Exp. 08/20/2023)

NB2061A (Exp. 09/14/2023)

NB2067A (Exp. 09/22/2023)

NDC:

69374-316-25

Packaged in 15 x 1 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (4 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 16 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

NB2017A (Exp. 03/04/2023)

NB2019A (Exp. 02/21/2023)

NB2024A (Exp. 03/27/2023)

NB2025A (Exp. 03/24/2023)

NB2027A (Exp. 04/07/2023)

NB2035A (Exp. 05/22/20123)

NB2038A (Exp. 06/02/2023)

NB2045A (Exp. 06/25/2023)

NB2053A (Exp. 07/29/2023)

NB2058B (Exp. 08/16/2023)

NB2064A (Exp. 09/07/2023)

NB2069A (Exp. 09/25/2023)

NB2071A (Exp. 10/01/2023)

NDC:

69374-319-25

Packaged in 15 IV Bottles per carton

Product: Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP (16 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 64 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

NB2018A (Exp. 02/24/2023)

NB2022A (Exp. 03/08/2023)

NB2028A (Exp. 04/04/2023)

NB2032A (Exp. 04/24/2023)

NB2036A (Exp. 05/24/2023)

NB2043A (Exp. 06/17/2023)

NB2046A (Exp. 06/26/2023)

NB2049A (Exp. 07/21/2023)

NB2052A (Exp. 07/27/2023)

NB2062A (Exp. 09/13/2023)

NB2068A (Exp. 09/23/2023)

NDC:

69374-315-25

Packaged in 15 IV Bottles per carton

Product: Phenylephrine HCl Injection, USP (1 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 100 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2025 (Exp. 05/28/2023)

PE2026 (Exp. 06/02/2023)

PE2027 (Exp. 06/04/2023)

PE2030 (Exp. 06/29/2023)

PE2031 (Exp. 06/27/2023)

PE2032 (Exp. 07/09/2023)

PE2032A (Exp. 07/09/2023)

PE2033 (Exp. 08/03/2023)

PE2034 (Exp. 08/31/2023)

PE2035 (Exp. 09/11/2023)

NDC:

69374-302-10

Packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl Injection, USP (0.4 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 40 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2028 (Exp. 06/15/2023)

NDC:

69374-305-10

Packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl Injection, USP (0.8 mg/10 mL)by Nephron 503B Outsourcing Facility

Variants: 80 mcg/mL, 10 mL Single-Dose Vial

Lot Numbers:

PE2029 (Exp. 06/17/2023)

NDC:

69374-301-10

Packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials per case

Product: Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP (50 mg/250 mL)by Nephron 503B Outsourcing Facility

Variants: 200 mcg/mL, 250 mL Single-Dose Container bottle

Lot Numbers:

PS2008A (Exp. 03/07/2023)

NDC:

69374-321-25

Packaged in 15 x 1 IV Bottles per carton

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91749

Status: Resolved

Manufacturer: Nephron Sterile Compounding Center LLC

Sold By: Hospitals; Clinics; Nephron 503B Outsourcing Facility

Manufactured In: United States

Units Affected: 8 products (4,743 bottles; 443,483 bottles; 305,895 bottles; 270,291 bottles; 546,450 vials; 31,500 vials; 24,870 vials; 10,980 bottles)

Distributed To: Nationwide