- Company Announcement Date:
- November 12, 2021
- FDA Publish Date:
- November 15, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Lack of sterility assurance
- Company Name:
- SterRx, LLC
- Brand Name:
- Product Description:
SterRx products intended to be sterile
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:
- lmg/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
Product images are available on www.sterrx.com
Lot information is available at www.sterrx.com/resources
Customers are being notified by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product. The necessary form to document product information, as well as other information regarding this recall, is available at www .sterrx.com.
Customers or healthcare workers with any questions about returning unused product should be directed to the customer call center at (518) 324-7983 M-F 8:00am to 5:00pm EST or email [email protected]. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Company Contact Information
- Customer Call Center
- (518) 324-7983