FDA Recall Alert: Downing Labs, LLC Issues Voluntary Recall of Sterile Compounded Products for Lack of Sterility Assurance

On October 21, the Food and Drug Administration (FDA) alerted providers that Downing Labs, LLC will initiate a voluntary recall of all lots of sterile products aseptically compounded and packaged by Downing Labs and that remain within expiration dates, due to concerns over a lack of sterility assurance. The sterile products were distributed nationwide and in the UK to patients, providers, hospitals, or clinics between April 20, 2015 and September 15, 2015. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. 

Downing Labs asks all patients and providers who received sterile compounded products from Downing Labs between April 20, 2015 and September 15, 2015 to take the following actions: discontinue use of the product, quarantine any unused product until further instructions on how to return the product and contact Downing Labs at 800-914-7435, or email pharacist@downinglabs.com to discuss the return of any unused product.

Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Providers who have dispensed any sterile product distributed by Downing Labs to patients for use outside of the provider's office should contact the patients to whom the product was dispensed and advise the patients of this recall.

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: www.fda.gov/medwatch/report.htm.
  • 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.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org or 703-591-2220.