Medicine recalls
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| The United States: FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy |
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The US Food and Drug Administration (FDA) is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.
The recalled drugs include “gonadorelin acetate,” “testosterone cypionate in grapeseed oil,” “testosterone cypionate/anastrozole in grapeseed oil,” “testosterone cypionate/DHEA in grapeseed oil,” and “testosterone cypionate/propionate in sesame seed oil” for human use, and “cyclosporin” and “tacrolimus” for animal ophthalmic use. These products were compounded between 21 Dec 2021 and 7 Mar 2022. For details of the affected products, please refer to the website in FDA.
Since the company initiated the recall and began contacting patients using the recalled drugs, FDA has received adverse event reports from APS Pharmacy regarding injection site reactions, such as pain, redness, swelling and abscesses requiring medical treatment; and systemic reactions, which include fever, chills, and rash. To date, FDA has received two reports of adverse events occurring in animals following use of the recalled animal ophthalmic products.
Patients should not use, and animal owners/caretakers should not administer, the recalled drugs from APS Pharmacy. If they are not sure if they have a recalled drug, they should contact APS pharmacy to confirm. Patients who have received these recalled drugs from APS Pharmacy should contact their health care professional. Animal owners/caretakers should contact their veterinarian as appropriate.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-customers-voluntary-recall-compounded-drugs-due-sterility-issues-drug-depot-llc-dba-aps
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by the above company.
Ends/Wednesday, Apr 27, 2022
Issued at HKT 14:30
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