FDA Drug recall D-0065-2023
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension…
- FDA Drug
- Class II
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension… 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-0065-2023 |
| 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-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
Reason
CGMP Deviations: Potential for cross contamination due to product carry over.
Identifiers
| upc | 369374932332 |
|---|---|
| code_info | Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022. |
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-0065-2023%22
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