FDAFDA · Food and drugs·Recall number D-0148-2020
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
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: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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