SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

SterRx, LLC today announced the voluntary nationwide recall of approximately 240 lots within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance for products intended to be sterile. To date, SterRx, LLC has not received reports of any product complaints or adverse events associated with this issue. SterRx, LLC has initiated this voluntary recall to the hospital pharmacy level out of an abundance of caution.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The lot numbers being recalled were distributed to hospitals nationwide from December 2020- October 2021. The products impacted are specifically:

  • 1 mg/ml Midazolam in 0.9% Sodium Chloride

  • Fentanyl in 0.9% Sodium Chloride

  • lmg/ml Morphine Sulfate in 0.9% Sodium Chloride

  • lmg/ml Morphine Sulfate in 5% Dextrose

  • 125mg Diltiazem HCL in 0.7% Sodium Chloride

  • 125mg 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

  • 150mEq Sodium Bicarbonate in 5% Dextrose

  • 200mg Succinylcholine Chloride in 0.9% Sodium Chloride

For a full list of the SterRx lots affected please click here.


TOPIC: Certain SterRx Products by SterRx: Recall - Due to Lack of Sterility Assurance AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: SterRx is recalling approximately 240 lots due to equipment and process issues that could lead to a lack of sterility assurance. To date, SterRx has not received reports of any product complaints or adverse events associated with this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The lot numbers being recalled were distributed to hospitals nationwide from December 2020 - October 2021. The products impacted are specifically:

  • 1 mg/mL Midazolam in 0.9% Sodium Chloride

  • Fentanyl in 0.9% Sodium Chloride

  • 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride

  • 1 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

RECOMMENDATIONS:

  • Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product.

  • Customers or healthcare workers with questions about returning unused product should contact the company's customer call center.

  • Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.


Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.


Read Recall



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