FDA MedWatch - Certain SterRx Products by SterRx: Recall - Due to Lack of Sterility Assurance

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program 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.

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