The Recall Desk

FDA (Drugs) recall action 83999

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalled 2 products on 2019-10-30

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-10-30
Critical
0
Units
1,209

Why these products were recalled

Lack of Assurance of Sterility; bags have potential to leak

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.

1–2 of 2

  • SevereFDA (Drugs)··2019-10-30

    Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns

    Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-10-30

    Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.

    Product
    del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
    Category
    Distribution
    0 states