Medications & Supplements/Prescription Drugs

Nephron Injectable Medications Recalled for Potential Cross-Contamination

Agency Publication Date: August 16, 2022

Summary

Nephron Sterile Compounding Center LLC is recalling 49,694 units of various injectable medications, including Neostigmine Methylsulfate, Trisodium Citrate, Bupivacaine HCl, and Labetalol HCl. The recall was initiated because of manufacturing deviations that may have allowed different drug products to mix or contaminate each other during production. No incidents or injuries have been reported to date. These products were distributed nationwide in the USA to clinics, hospitals, and pharmacies.

Risk

The potential for cross-contamination means that patients could receive a medication containing traces of a different drug substance. This could lead to unexpected side effects, allergic reactions, or adverse interactions with other medications the patient is receiving.

What You Should Do

This recall affects multiple injectable drug products, including Neostigmine Methylsulfate (NDC 69374-932-33), Trisodium Citrate (NDC 69374-910-04), Bupivacaine HCl (NDC 69374-970-05), and Labetalol HCl (NDC 69374-946-34).
Check your medical inventory for the following lot numbers and expiration dates: NE1057A (Exp 10/23/2022), TC2007D (Exp 8/26/2022), TC2010A (Exp 9/25/2022), BH2003A (Exp 8/19/2022), BH2011A (Exp 11/9/2022), and LB2005A (Exp 3/2/2023).
Stop using the recalled product immediately. Contact the manufacturer, Nephron Sterile Compounding Center LLC, or your medical distributor to arrange for the return of any remaining supply.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse reactions.

Your Remedy Options

Other Action

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

Affected Products

Product: PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL)

Variants: One 3 mL Unit-Dose Vial, 30 x 3 mL Sterile Unit-Dose Vials per carton

Lot Numbers:

NE1057A (Exp. 10/23/2022)

NDC:

69374-932-33

Quantity: 13,500 vials

Product: Trisodium Citrate 0.5% Solution, (0.5%/4L)

Variants: 4000 mL IV bag, 1 x 1 IV bag per carton

Lot Numbers:

TC2007D (Exp. 8/26/2022)

TC2010A (Exp. 9/25/2022)

NDC:

69374-910-04

Quantity: 294 bags

Product: PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL)

Variants: 500 mL bag, 10 x 1 IV Bag per case

Lot Numbers:

BH2003A (Exp. 8/19/2022)

BH2011A (Exp. 11/9/2022)

NDC:

69374-970-05

Quantity: 2030 bags

Product: PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL)

Variants: One 4 mL Unit-Dose Vial, 30 x 4 mL Sterile Unit-dose Vials per carton

Lot Numbers:

LB2005A (Exp 3/2/2023)

NDC:

69374-946-34

Quantity: 33,870 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90718

Status: Resolved

Manufacturer: Nephron Sterile Compounding Center LLC

Sold By: Clinics; Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 4 products (13,500 vials; 294 bags; 2030 bags; 33,870 vials)

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 multiple injectable drug products, including Neostigmine Methylsulfate (NDC 69374-932-33), Trisodium Citrate (NDC 69374-910-04), Bupivacaine HCl (NDC 69374-970-05), and Labetalol HCl (NDC 69374-946-34).

Check your medical inventory for the following lot numbers and expiration dates: NE1057A (Exp 10/23/2022), TC2007D (Exp 8/26/2022), TC2010A (Exp 9/25/2022), BH2003A (Exp 8/19/2022), BH2011A (Exp 11/9/2022), and LB2005A (Exp 3/2/2023).

Stop using the recalled product immediately. Contact the manufacturer, Nephron Sterile Compounding Center LLC, or your medical distributor to arrange for the return of any remaining supply.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse reactions.

Affected Products

Product: PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL)

Variants: One 3 mL Unit-Dose Vial, 30 x 3 mL Sterile Unit-Dose Vials per carton

Lot Numbers:

NE1057A (Exp. 10/23/2022)

NDC:

69374-932-33

Quantity: 13,500 vials

Product: Trisodium Citrate 0.5% Solution, (0.5%/4L)

Variants: 4000 mL IV bag, 1 x 1 IV bag per carton

Lot Numbers:

TC2007D (Exp. 8/26/2022)

TC2010A (Exp. 9/25/2022)

NDC:

69374-910-04

Quantity: 294 bags

Product: PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL)

Variants: 500 mL bag, 10 x 1 IV Bag per case

Lot Numbers:

BH2003A (Exp. 8/19/2022)

BH2011A (Exp. 11/9/2022)

NDC:

69374-970-05

Quantity: 2030 bags

Product: PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL)

Variants: One 4 mL Unit-Dose Vial, 30 x 4 mL Sterile Unit-dose Vials per carton

Lot Numbers:

LB2005A (Exp 3/2/2023)

NDC:

69374-946-34

Quantity: 33,870 vials