Downing Labs, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to Lack of Sterility Assurance
FOR IMMEDIATE RELEASE – October 20, 2015 – Farmers Branch, TX – Downing Labs, LLC ("Downing Labs") is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. The recall does not pertain to any non-sterile compounded medications prepared by Downing Labs.
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. There have been no consumer complaints or reports of any issues with the recalled products to date. Downing Labs takes this measure voluntarily and solely out of an abundance of caution because Downing Labs takes the utmost care to ensure patient safety. Thus, Downing Labs is asking all patients and providers that received sterile compounded products from Downing Labs between April 20, 2015 and September 15, 2015 that remain within expiry to take the following actions:
Discontinue use of the products;
Set aside any unused product until further instructions are received on how to return the product; and
Contact Downing Labs at 800-914-7435 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at email@example.com to discuss the return of any unused sterile compounded products.
Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by Downing Labs to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.
Adverse reactions or quality problems experienced with the use of these products 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: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the FDA.
Again, no consumer complaints have been received. Downing Labs’ primary concern is your safety and thus Downing Labs is taking this action out of an abundance of caution. Thank you for your continued support.