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
Reported: October 30, 2019 Initiated: October 9, 2019 #D-0148-2020
Product Description
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
Reason for Recall
GMP Deviations: potential glass contamination
Details
- Units Affected
- 1370 bags
- Distribution
- Nationwide.
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center. Units affected: 1370 bags.
Why was this product recalled? ▼
GMP Deviations: potential glass contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 30, 2019. Severity: Moderate. Recall number: D-0148-2020.
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