Compounded drugs were produced under poor sterile production practices in an inadequately designed processing room
[12/7/2018] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
During FDA’s recent inspection of Promise Pharmacy’s facility, investigators observed insanitary conditions, including poor sterile production practices and inadequate design of one of its processing rooms, which raised concerns about the company’s ability to assure the sterility of its drug products from that processing room.
Examples of products compounded in this room include bremelanotide, sermorelin, BPC-157, arginine HCL, leucine/isoleucine/valine, dexapanthenol and/or ascorbic acid. There may be additional drug products that were compounded in that processing room.
Health care professionals should contact Promise Pharmacy for any questions concerning whether drug products obtained from the pharmacy were produced in the inadequately designed processing room and immediately check their medical supplies, quarantine any purportedly sterile drug products of concern, and not administer them to patients. Health care professionals should also make alternative arrangements to replace any medications produced in the inadequately designed processing room from reliable sources that adhere to proper quality standards.
Patients who have received drug products intended to be sterile compounded by Promise Pharmacy and have concerns should consult their health care professional.
On November 13, 2018, FDA recommended that Promise Pharmacy recall all unexpired drug products intended to be sterile and cease sterile operations until the company makes adequate corrections at its facility. On November 14 and November 19, 2018, Promise Pharmacy informed FDA that it would voluntarily cease sterile operations in the inadequately designed processing room; however, the company refused to recall drug products it compounded in that room.
During FDA’s recent inspection, on October 22, 2018, Promise Pharmacy did conduct a limited voluntary recall of prednisolone and gatifloxacin ophthalmic solutions due to small particulate floating in the solutions.
FDA is not aware of any recent adverse events associated with the use of products from Promise Pharmacy. FDA encourages Health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the MedWatch Adverse Event Reporting program by:
- Completing and submit the report online at www.fda.gov/medwatch/report.htm; or
- Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.
