FDA Drug recall D-0149-2020
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only…
- 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* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only… by Nephron Pharmaceuticals, citing GMP Deviations: potential glass contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0149-2020 |
| 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* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
Reason
GMP Deviations: potential glass contamination
Identifiers
| code_info | Lot: FR9002A Exp. 12/12/2019 |
|---|
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-0149-2020%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.