November 18, 2021

FDA: Nationwide recall of certain SterRx drug products

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA), on November 15, announced the nationwide recall by SterRx, LLC, of 240 lots of its drug products.

The recall was initiated because of the lack of sterility assurance due to equipment and process issues.

The recalled drugs include:

  • l mg/ml Midazolam in 0.9% Sodium Chloride
  • Fentanyl in 0.9% Sodium Chloride
  • l mg/ml Morphine Sulfate in 0.9% Sodium Chloride
  • l mg/ml Morphine Sulfate in 5% Dextrose
  • 125 mg Diltiazem HCL in 0.7% Sodium Chloride
  • 125 mg Diltiazem HCL in 5% Dextrose
  • Norepinephrine in 0.9% Sodium Chloride
  • Norepinephrine in 5% Dextrose
  • Epinephrine in 0.9% Sodium Chloride
  • Phenylephrine in 0.9% Sodium Chloride
  • 150 mEq Sodium Bicarbonate in 5% Dextrose
  • 200 mg Succinylcholine Chloride in 0.9% Sodium Chloride.

The lots were distributed from December 2020 to October 2021.

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