FDAFDA · Food and drugs·Recall number 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 Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
Published October 30, 2019 · Recall initiated: October 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP Deviations: potential glass contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Distributor
- Nationwide.
- Lot
- Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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