Other safety alerts
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| The United States: FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection |
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The US Food and Drug Administration (FDA) received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, LLC, located in West Palm Beach, Florida. According to the report, a sample of the product was sent for testing and the pH was determined to be above 11.
FDA conducted a for-cause inspection of United Pharmacy and collected samples from two batches of GAC injectable product. Analysis performed on the samples determined the pH to be 10.9, which is alkaline, and no glutamine was detected. Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences. United Pharmacy recalled lots GAC-12 and GAC-13 on 27 Sep 2017.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/../ucm584125.htm
In Hong Kong, the above compounded product is not a registered pharmaceutical product. There is also no registered pharmaceutical product manufactured by United Pharmacy, LLC.
Ends/Thursday, Nov 9, 2017
Issued at HKT 14:00
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