CLASS II Drug recall · Reported 23 Nov 2022 · FDA Enforcement Report
PF-Labetalol HCl Injection, USP 20 mg/ (5 mg/mL) vial recalled
Nephron Sterile Compounding Center is recalling PF-Labetalol HCl Injection, USP 20 mg/ (5 mg/mL) vial, distributed nationwide in the US. The recall was initiated on 10 Nov 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0064-2023
- FDA event ID
- 91132
- Recalling firm
- Nephron Sterile Compounding Center, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2022
- FDA classified
- 17 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Nov 2022 | Recall initiated by company | |
| 17 Nov 2022 | Classified by FDA | +7 days |
| 23 Nov 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Potential for cross contamination due to product carry over.
Which lots are affected?
Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91132This product is part of a recall event; the main page for the event is PF-Neostigmine Methylsulfate Injection, USP 3 mg/ (1 mg/mL) vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PF-Neostigmine Methylsulfate Injection, USP 3 mg/ (1 mg/mL) vial recalled | Nephron Sterile Compounding Center | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Nephron Sterile Compounding Center
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Injection 9%, USP, Single-Dose IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.8 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl Injection, USP, 0.4 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
Other Pf-labetalol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PF-Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled | Nephron Sterile Compounding Center | Manufacturing (CGMP) Deviations | Nationwide |