The Recall Desk

FDA (Drugs) recall action 91132

Nephron Sterile Compounding Center LLC recalled 2 products on 2022-11-23

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
2022-11-23
Critical
0
Units
90,240

Why these products were recalled

CGMP Deviations: Potential for cross contamination due to product carry over.

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

  • ModerateFDA (Drugs)··2022-11-23

    Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls

    Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.

    Product
    PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2022-11-23

    FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk

    FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.

    Product
    PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
    Category
    Distribution
    0 states