The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

“We are fully cooperating with health officials,” said Denise Burnham, R.Ph., owner and pharmacist. “We deeply regret the impact this voluntary recall has on our customers, but patient safety is our highest priority.”

All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and distributed to health care facilities, physicians, and patients in two states, Oregon and Washington.

The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.

All unexpired lots of the following sterile compounded products are subject to the recall:

The company has begun notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products. To return product or request assistance related to this recall, users should call 503-685-6111 or 877-585-6111, Monday through Friday, from 9:30 a.m. to 1 p.m. and 1:30 to 5:30 p.m. PDT.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking these drug products. Adverse reactions 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

• Online: Complete and submit a report at www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and mail to 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 U.S. Food and Drug Administration.