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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nephron Labetalol and Neostigmine Injections Recalled for Contamination Risk

Agency Publication Date: November 17, 2022
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Summary

Nephron Sterile Compounding Center LLC is recalling 90,240 vials of Labetalol HCl and Neostigmine Methylsulfate injections due to potential cross-contamination during manufacturing. The recall affects 34,020 vials of Labetalol HCl (20 mg/4 mL) and 56,220 vials of Neostigmine Methylsulfate (3 mg/3 mL). The company initiated the recall after discovering manufacturing deviations that could allow product carry-over between different drug batches. No incidents or injuries have been reported to date. Hospitals and clinics should stop using these specific lots and contact the manufacturer for instructions.

Risk

The potential for cross-contamination means patients could receive unintended drug substances or impurities. This carry-over could cause unpredictable pharmacological reactions or interfere with the intended efficacy of the sterile injections.

What You Should Do

  1. This recall affects Nephron Labetalol HCl Injection (NDC 69374-946-34) and Neostigmine Methylsulfate Injection (NDC 69374-932-33) sold in 3 mL and 4 mL vials.
  2. Identify affected products by checking for the following lot numbers: LB2001B, LB2005B, NE1062A, NE1062B, NE1065A, NE1065B, NE2011A, or NE2011B.
  3. Stop using the recalled injections immediately and quarantine all remaining inventory.
  4. Contact Nephron Sterile Compounding Center LLC or your wholesale distributor to arrange for the return of the affected products.
  5. For additional questions or to report adverse events, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vialby Nephron
Variants: 20 mg/4 mL, Single-dose vial
UPC Codes:
369374946346
Lot Numbers:
LB2001B (Exp. 01/07/2023)
LB2005B (Exp. 03/02/2023)
NDC:
69374-946-34

Rx Only

Product: PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vialby Nephron
Variants: 3 mg/3 mL, Single-dose vial
UPC Codes:
369374932332
Lot Numbers:
NE1062A (Exp. 12/02/2022)
NE1062B (Exp. 12/02/2022)
NE1065A (Exp. 12/13/2022)
NE1065B (Exp. 12/13/2022)
NE2011A (Exp. 03/15/2022)
NE2011B (Exp. 03/15/2022)
NDC:
69374-932-33

Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91132
Status: Resolved
Manufacturer: Nephron Sterile Compounding Center LLC
Sold By: Hospitals; Clinics; Healthcare Facilities
Manufactured In: United States
Units Affected: 2 products (34,020 vials; 56,220 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 ยท 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.