The FDA has issued an alert to health care professionals and patients to not use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy.
“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” the FDA wrote in a news release.
According to the FDA, during a recent inspection of Promise Pharmacy’s facility, in Palm Harbor, FL, FDA investigators found insanitary conditions. Among the conditions observed were poor sterile production practices and inadequate design of one of its processing rooms. The FDA was concerned about the company’s ability to assure the sterility of its drug products from that processing room.
The FDA said that products compounded in the room that was investigated include:
- arginine HCL;
- dexapanthenol; and/or,
- ascorbic acid.
The agency noted that there may be additional drug products that were compounded in the processing room.
The FDA has instructed health care professionals to contact Promise Pharmacy with any questions concerning drug products that were obtained from the pharmacy which were produced in the processing room in question. Further, health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products of concern, and not administer them to patients. Professionals should also make alternative arrangements to replace any medications produced in that processing room.
Patients should contact their health care professional if they received drug products that were produced in Promise Pharmacy’s insanitary processing room, as well.
The FDA noted that on November 13, 2018 the FDA recommended the pharmacy recall all unexpired drug products intended to be sterile and cease sterile operations until the company makes adequate corrections at its facility. Further, 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 pharmacy said it would not recall drug compounds from the room that was investigated.
On October 22, 2018 a limited voluntary recall of prednisolone and gatifloxacin ophthalmic solutions due to small particulate floating in the solutions was conducted by Promise Pharmacy.
For more Pharmacy Learning Network articles, visit the homepage