PF-Fentanyl Citrate — Class II drug recall D-0147-2020
Terminated recall by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, reported 2019-10-30, distributed nationwide. GMP Deviations: potential glass contamination
| Recall number | D-0147-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, West Columbia, SC, United States |
| Recall initiated | 2019-10-09 |
| Classified | 2019-10-18 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,855 bags |
| Reason classes | foreign material, cgmp |
| NDC | 69374-0525-25 |
| Lot numbers | FB9001A, FB9001B, FB9013A, FB9015A |
| Expiration dates | 2019-10-31, 2019-12-08, 2019-12-14 |
Product
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
Reason for recall
GMP Deviations: potential glass contamination
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-0147-2020. 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.