Medications & Supplements/Prescription Drugs

Nephron Sterile Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: May 27, 2022

Summary

Nephron Sterile Compounding Center LLC is recalling approximately 2,158,351 units of various sterile injectable medications, such as Epinephrine, Fentanyl, and Ketamine, among others. These products were distributed nationwide to hospitals, clinics, and other healthcare facilities and are intended for injection. The recall was initiated because the manufacturer cannot guarantee the sterility of these medications, though no injuries or illnesses have been reported to date.

Risk

Using a medication that is not properly sterilized can introduce bacteria or other harmful contaminants directly into a patient's bloodstream. This poses a serious risk of life-threatening infections and other severe health complications for patients receiving these injections.

What You Should Do

This recall affects over 2 million units of various Nephron brand sterile injectable medications, including Sodium Bicarbonate, Calcium Gluconate, Epinephrine, Fentanyl, Glycopyrrolate, Hydromorphone, Ketamine, Labetalol, Lidocaine, Neostigmine, Oxytocin, Phenylephrine, Rocuronium, and Succinylcholine.
Affected products can be identified by the Nephron 503B outsourcing facility label and specific National Drug Code (NDC) and lot numbers printed on the syringe cartons or IV bags. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
Contact Nephron Sterile Compounding Center LLC or your distributor to arrange for the return of any remaining affected products.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

Other Action

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

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP

Variants: 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe

Lot Numbers:

SB2001A (Exp. 1/2/2023)

SB2005B (Exp. 3/8/2023)

SB2005C (Exp. 3/8/2023)

SB2006A (Exp. 3/16/2023)

SB2006B (Exp. 3/16/2023)

SB2006C (Exp. 3/16/2023)

NDC:

69374-214-50

Packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton; Rx Only; Nephron 503B outsourcing facility

Product: Calcium Gluconate Injection, USP 10%

Variants: 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

CG1003A (Exp. 12/3/2022)

CG2001A (Exp. 2/10/2023)

NDC:

69374-950-10

5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: EPINEPHrine Injection, USP

Variants: 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

EN2005A (Exp. 7/25/2022)

EN2009A (Exp. 8/20/2022)

EN2010A (Exp. 9/13/2022)

NDC:

69374-544-10

5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Epinephrine Injection, USP

Variants: 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

EN1047A (Exp. 6/7/2022)

EN2002A (Exp. 7/7/2022)

EN2006A (Exp. 7/19/2022)

EN2011A (Exp. 9/1/2022)

NDC:

69374-925-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP

Variants: 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag

Lot Numbers:

FN1088A (Exp. 6/21/2022)

FN1089A (Exp. 6/26/2022)

NDC:

69374-523-21

10 x 1 IV Bag; Rx Only; Nephron 503B outsourcing facility

Product: Glycopyrrolate Injection, USP (1 mg)

Variants: 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

GL2002B (Exp. 8/13/2022)

NDC:

69374-903-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Glycopyrrolate Injection, USP (0.6 mg)

Variants: 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe

Lot Numbers:

GL2002A (Exp. 8/13/2022)

NDC:

69374-903-03

5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Hydromorphone HCl Injection, USP (50 mg)

Variants: 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe

Lot Numbers:

HN2005A (Exp. 9/17/2022)

NDC:

69374-559-50

5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Hydromorphone HCl Injection, USP (6 mg)

Variants: 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe

Lot Numbers:

HH2008A (Exp. 9/5/2022)

NDC:

69374-529-30

5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Ketamine Hydrochloride Injection, USP (30 mg)

Variants: 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe

Lot Numbers:

KH2008A (Exp. 8/8/2022)

NDC:

69374-982-33

5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Ketamine Hydrochloride Injection, USP (50 mg)

Variants: 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe

Lot Numbers:

KH1086A (Exp. 6/24/2022)

KH2002B (Exp. 7/5/2022)

KH2008B (Exp. 8/8/2022)

KH2012A (Exp. 8/23/2022)

NDC:

69374-982-55

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Labetalol HCl Injection, USP

Variants: 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe

Lot Numbers:

LB1020A (Exp. 5/21/2022)

LB1022A (Exp. 5/21/2022)

LB2003A (Exp. 8/5/2022)

LB2007A (Exp. 9/20/2022)

NDC:

69374-946-04

5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Lidocaine HCl Injection, USP, 2%

Variants: 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

LI2001A (Exp. 6/8/2022)

NDC:

69374-949-05

5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Neostigmine Methylsulfate Injection, USP

Variants: 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

NE2001A (Exp. 6/30/2022)

NE2009B (Exp. 8/27/2022)

NDC:

69374-902-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Oxytocin in 0.9% Sodium Chloride Injection, USP

Variants: 30 Units/500 mL (0.06 Units/mL), 500 mL Single-Dose Container Bag

Lot Numbers:

OX2008C (Exp. 5/27/2022)

OX2010C (Exp. 6/17/2022)

OX2011C (Exp. 6/24/2022)

OX2011D (Exp. 6/24/2022)

NDC:

69374-543-50

10 x 1 IV Bag; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (0.4 mg)

Variants: 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

PE1108A (Exp. 5/27/2022)

PE2006A (Exp. 8/3/2022)

PE2010A (Exp. 8/12/2022)

NDC:

69374-955-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (0.8 mg)

Variants: 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes

Lot Numbers:

PE1107A (Exp. 5/22/2022)

PE1123A (Exp. 6/21/2022)

PE2007A (Exp. 8/4/2022)

PE2012A (Exp. 8/28/2022)

NDC:

69374-956-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (1 mg)

Variants: 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

PE1115B (Exp. 5/31/2022)

PE1115C (Exp. 5/31/2022)

PE1122A (Exp. 6/19/2022)

PE2004B (Exp. 7/11/2022)

PE2004C (Exp. 7/11/2022)

PE2011A (Exp. 8/22/2022)

PE2011C (Exp. 8/22/2022)

PE2015A (Exp. 9/5/2022)

PE2015B (Exp. 9/5/2022)

PE2015C (Exp. 9/5/2022)

PE2016A (Exp. 9/13/2022)

PE2016B (Exp. 9/13/2022)

PE2016C (Exp. 9/13/2022)

NDC:

69374-957-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Rocuronium Bromide Injection

Variants: 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

RC1050A (Exp. 5/30/2022)

RC1051B (Exp. 6/6/2022)

RC1053A (Exp. 6/27/2022)

RC2001A (Exp. 7/19/2022)

RC2002A (Exp. 8/13/2022)

RC2003A (Exp. 8/28/2022)

RC2004A (Exp. 9/8/2022)

NDC:

69374-924-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Succinylcholine Chloride Injection, USP

Variants: 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

SU2004A (Exp. 5/18/2022)

SU2007A (Exp. 6/2/2022)

NDC:

69374-920-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90211

Status: Resolved

Manufacturer: Nephron Sterile Compounding Center LLC

Sold By: Hospitals; Clinics; Healthcare Facilities

Manufactured In: United States

Units Affected: 20 products (13612 syringes; 30180 syringes; 35850 syringes; 134415 syringes; 3532 bags; 32,550 syringes; 6150 syringes; 2795 syringes; 6210 syringes; 30,290 syringes; 107530 syringes; 115640 syringes; 65590 syringes; 64450 syringes; 3587 bags; 57810 syringes; 76860 syringes; 585660 syringes; 604080 syringes; 181560 syringes)

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 over 2 million units of various Nephron brand sterile injectable medications, including Sodium Bicarbonate, Calcium Gluconate, Epinephrine, Fentanyl, Glycopyrrolate, Hydromorphone, Ketamine, Labetalol, Lidocaine, Neostigmine, Oxytocin, Phenylephrine, Rocuronium, and Succinylcholine.

Affected products can be identified by the Nephron 503B outsourcing facility label and specific National Drug Code (NDC) and lot numbers printed on the syringe cartons or IV bags. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

Contact Nephron Sterile Compounding Center LLC or your distributor to arrange for the return of any remaining affected products.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP

Variants: 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe

Lot Numbers:

SB2001A (Exp. 1/2/2023)

SB2005B (Exp. 3/8/2023)

SB2005C (Exp. 3/8/2023)

SB2006A (Exp. 3/16/2023)

SB2006B (Exp. 3/16/2023)

SB2006C (Exp. 3/16/2023)

NDC:

69374-214-50

Packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton; Rx Only; Nephron 503B outsourcing facility

Product: Calcium Gluconate Injection, USP 10%

Variants: 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

CG1003A (Exp. 12/3/2022)

CG2001A (Exp. 2/10/2023)

NDC:

69374-950-10

5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: EPINEPHrine Injection, USP

Variants: 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

EN2005A (Exp. 7/25/2022)

EN2009A (Exp. 8/20/2022)

EN2010A (Exp. 9/13/2022)

NDC:

69374-544-10

5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Epinephrine Injection, USP

Variants: 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

EN1047A (Exp. 6/7/2022)

EN2002A (Exp. 7/7/2022)

EN2006A (Exp. 7/19/2022)

EN2011A (Exp. 9/1/2022)

NDC:

69374-925-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP

Variants: 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag

Lot Numbers:

FN1088A (Exp. 6/21/2022)

FN1089A (Exp. 6/26/2022)

NDC:

69374-523-21

10 x 1 IV Bag; Rx Only; Nephron 503B outsourcing facility

Product: Glycopyrrolate Injection, USP (1 mg)

Variants: 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

GL2002B (Exp. 8/13/2022)

NDC:

69374-903-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Glycopyrrolate Injection, USP (0.6 mg)

Variants: 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe

Lot Numbers:

GL2002A (Exp. 8/13/2022)

NDC:

69374-903-03

5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Hydromorphone HCl Injection, USP (50 mg)

Variants: 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe

Lot Numbers:

HN2005A (Exp. 9/17/2022)

NDC:

69374-559-50

5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Hydromorphone HCl Injection, USP (6 mg)

Variants: 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe

Lot Numbers:

HH2008A (Exp. 9/5/2022)

NDC:

69374-529-30

5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Ketamine Hydrochloride Injection, USP (30 mg)

Variants: 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe

Lot Numbers:

KH2008A (Exp. 8/8/2022)

NDC:

69374-982-33

5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Ketamine Hydrochloride Injection, USP (50 mg)

Variants: 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe

Lot Numbers:

KH1086A (Exp. 6/24/2022)

KH2002B (Exp. 7/5/2022)

KH2008B (Exp. 8/8/2022)

KH2012A (Exp. 8/23/2022)

NDC:

69374-982-55

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Labetalol HCl Injection, USP

Variants: 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe

Lot Numbers:

LB1020A (Exp. 5/21/2022)

LB1022A (Exp. 5/21/2022)

LB2003A (Exp. 8/5/2022)

LB2007A (Exp. 9/20/2022)

NDC:

69374-946-04

5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Lidocaine HCl Injection, USP, 2%

Variants: 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

LI2001A (Exp. 6/8/2022)

NDC:

69374-949-05

5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Neostigmine Methylsulfate Injection, USP

Variants: 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

NE2001A (Exp. 6/30/2022)

NE2009B (Exp. 8/27/2022)

NDC:

69374-902-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Oxytocin in 0.9% Sodium Chloride Injection, USP

Variants: 30 Units/500 mL (0.06 Units/mL), 500 mL Single-Dose Container Bag

Lot Numbers:

OX2008C (Exp. 5/27/2022)

OX2010C (Exp. 6/17/2022)

OX2011C (Exp. 6/24/2022)

OX2011D (Exp. 6/24/2022)

NDC:

69374-543-50

10 x 1 IV Bag; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (0.4 mg)

Variants: 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

PE1108A (Exp. 5/27/2022)

PE2006A (Exp. 8/3/2022)

PE2010A (Exp. 8/12/2022)

NDC:

69374-955-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (0.8 mg)

Variants: 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes

Lot Numbers:

PE1107A (Exp. 5/22/2022)

PE1123A (Exp. 6/21/2022)

PE2007A (Exp. 8/4/2022)

PE2012A (Exp. 8/28/2022)

NDC:

69374-956-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Phenylephrine HCl Injection, USP (1 mg)

Variants: 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe

Lot Numbers:

PE1115B (Exp. 5/31/2022)

PE1115C (Exp. 5/31/2022)

PE1122A (Exp. 6/19/2022)

PE2004B (Exp. 7/11/2022)

PE2004C (Exp. 7/11/2022)

PE2011A (Exp. 8/22/2022)

PE2011C (Exp. 8/22/2022)

PE2015A (Exp. 9/5/2022)

PE2015B (Exp. 9/5/2022)

PE2015C (Exp. 9/5/2022)

PE2016A (Exp. 9/13/2022)

PE2016B (Exp. 9/13/2022)

PE2016C (Exp. 9/13/2022)

NDC:

69374-957-10

5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Rocuronium Bromide Injection

Variants: 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

RC1050A (Exp. 5/30/2022)

RC1051B (Exp. 6/6/2022)

RC1053A (Exp. 6/27/2022)

RC2001A (Exp. 7/19/2022)

RC2002A (Exp. 8/13/2022)

RC2003A (Exp. 8/28/2022)

RC2004A (Exp. 9/8/2022)

NDC:

69374-924-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Product: Succinylcholine Chloride Injection, USP

Variants: 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe

Lot Numbers:

SU2004A (Exp. 5/18/2022)

SU2007A (Exp. 6/2/2022)

NDC:

69374-920-05

5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton; Rx Only; Nephron 503B outsourcing facility

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90211

Status: Resolved

Manufacturer: Nephron Sterile Compounding Center LLC

Sold By: Hospitals; Clinics; Healthcare Facilities

Manufactured In: United States

Distributed To: Nationwide