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.
