CLASS II Drug recall · Reported 30 Oct 2019 · FDA Enforcement Report
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl recalled
Nephron Pharmaceuticals is recalling PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection, distributed nationwide in the US. The recall was initiated on 9 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0148-2020
- FDA event ID
- 84000
- Recalling firm
- Nephron Pharmaceuticals, West Columbia, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2019
- FDA classified
- 18 Oct 2019
- Reported
- 30 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 9 Oct 2019 | Recall initiated by company | |
| 18 Oct 2019 | Classified by FDA | +9 days |
| 30 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: potential glass contamination
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
GMP Deviations: potential glass contamination
Which lots are affected?
Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84000| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide | |
| CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
More recalls from Nephron Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg recalled | Nephron Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | del Nido Cardioplegia Solution, Single-Dose Container recalled | Nephron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Amino Acid Injection (50 mg/mL) L-Arginine HCl recalled | Nephron Pharmaceuticals | Sterility | Nationwide |
Other Pf-fentanyl recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |