The Recall Desk

FDA (Drugs) recall action 84000

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalled 3 products on 2019-10-30

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-10-30
Critical
0
Units
3,840

Why these products were recalled

GMP Deviations: potential glass contamination

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • SevereFDA (Drugs)··2019-10-30

    Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.

    Product
    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-10-30

    Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 1,370 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.

    Product
    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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-10-30

    Nephron Recalls Fentanyl and Ropivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 615 bags of Fentanyl and Ropivacaine Injection due to potential glass contamination from GMP deviations.

    Product
    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
    Category
    Distribution
    0 states