FDA Drug recall D-0064-2023
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Colum…
- FDA Drug
- Class II
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Colum… by Nephron Sterile Compounding Center, citing CGMP Deviations: Potential for cross contamination due to product carry over.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0064-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-11-10 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: Potential for cross contamination due to product carry over.
Identifiers
| upc | 369374946346 |
|---|---|
| code_info | Lots: LB2001B Exp. 01/07/2023; LB2005B Exp. 03/02/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per car…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center - Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged i…
FDA Drug · Class II · 2023-03-08 · Nephron Sterile Compounding Center
All Nephron Sterile Compounding Center recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0064-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.