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
Reported: October 30, 2019 Initiated: October 9, 2019 #D-0149-2020
Product Description
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 for Recall
GMP Deviations: potential glass contamination
Details
- Units Affected
- 615 bags
- Distribution
- Nationwide.
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center. Units affected: 615 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-0149-2020.
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