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Class II: temporary or reversible health riskTerminated

Nephron Sterile Compounding Center PF-Labetalol HCl Injection Recall

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsou…

Nephron Sterile Compounding Center LLC · West Columbia, SC

Risk level
Class II
Reported by FDA
Nov 23, 2022
Recall ID
D-0064-2023
Check your lot numberHow we source this data

Summary

Nephron Sterile Compounding Center recalled PF-Labetalol HCl Injection starting Nov 10, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0064-2023 on Nov 23, 2022. Reason: CGMP Deviations: Potential for cross contamination due to product carry over. Status: Terminated.

Why it was recalled

CGMP Deviations: Potential for cross contamination due to product carry over.

Product description

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

Lot numbers, UPCs & expiration codes

Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0064-2023
Classification
Class II
Status
Terminated
Recall initiated
Nov 10, 2022
FDA report date
Nov 23, 2022
Quantity
34,020 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Nephron Sterile Compounding Center LLC

Original FDA data

Every field from FDA enforcement report D-0064-2023, exactly as published.

Show all FDA fields
City
West Columbia
State
SC
Status
Terminated
Country
United States
Event ID
91132
Address
4500 12th Street Ext
Code information
Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
Postal code
29172-3025
Report date
Nov 23, 2022
Product type
Drugs
Recall number
D-0064-2023
Classification
Class II
Recalling firm
Nephron Sterile Compounding Center LLC
Product quantity
34,020 vials
Termination date
Sep 24, 2024
Reason for recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Distribution pattern
Nationwide in the USA
Recall initiation date
Nov 10, 2022
Initial firm notification
Letter
Center classification date
Nov 17, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0064-2023, published Nov 23, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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