FDA Drug recall D-1347-2022
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, R…
- FDA Drug
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, R… by Nephron Sterile Compounding Center, citing CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1347-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-10 |
| Published | 2022-08-24 |
| 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), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Reason
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Identifiers
| code_info | Lot: LB2005A, Exp 3/2/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1347-2022%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.