FDA Drug recall D-0147-2020
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…
- FDA Drug
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of 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… by Nephron Pharmaceuticals, citing GMP Deviations: potential glass contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0147-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-09 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | US |
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
GMP Deviations: potential glass contamination
Identifiers
| code_info | Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019 |
|---|
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-0147-2020%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.