Other safety alerts
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| The United States: FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy |
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The US Food and Drug Administration (FDA) 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 13 Nov 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 14 Nov and 19 Nov 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 22 Oct 2018, Promise Pharmacy did conduct a limited voluntary recall of prednisolone and gatifloxacin ophthalmic solutions due to small particulate floating in the solutions.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm627929.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company. Related news was previously issued by FDA, and was posted on the Drug Office website on 23 Oct 2018.
Ends/Monday, Dec 10, 2018
Issued at HKT 15:00
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