PF-Neostigmine Methylsulfate Injection — Class II drug recall D-1344-2022
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2022-08-24, distributed nationwide. CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
| Recall number | D-1344-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sterile Compounding Center LLC, West Columbia, SC, United States |
| Recall initiated | 2022-08-10 |
| Classified | 2022-08-16 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2024-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 13,500 vials |
| Reason classes | cgmp |
| NDC | 69374-0932-33 |
| Lot numbers | NE1057A |
| Expiration dates | 2022-10-23 |
Product
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
Reason for recall
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1344-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.