Other safety alerts
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| The United States: Compounded glutamine, arginine, and carnitine product for injection by United Pharmacy: compounding risk alert - FDA investigates two adverse events |
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The US Food and Drug Administration (FDA) announces that FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
Previously, FDA reported the product was labeled as including 10 mg/mL of glutamine, but no glutamine was found in samples from lots GAC-12 or GAC-13 tested within expiry. Since that time, FDA tested two available samples of the glutamine active pharmaceutical ingredient (API) collected from the API supplier used by United Pharmacy and determined the average purity of the samples to be within the acceptable range at 98.1% and 98.6% of its labeled claim. FDA also further tested the United Pharmacy GAC-12 and GAC-13 samples to determine whether the glutamine degraded.
Glutamine is known to break down to ammonia and pyroglutamic acid in aqueous solutions. FDA laboratory analysis detected the presence of pyroglutamic acid within the samples in amounts roughly equivalent to the degradation of approximately 10mg/mL of glutamine. These data suggest that this formulation of glutamine was chemically unstable before the expiration date was reached. United Pharmacy recalled all of its GAC 10/100/200mg/mL for injection products and ceased production of this formulation on 21 Dec 2017, after FDA notified the compounder of these results.
FDA encourages compounders to perform stability studies for solutions containing glutamine to confirm that the glutamine is not degrading before the product’s specified BUD.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm584352.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. Related news was previously issued by FDA, and was posted on the Drug Office website on 9 Nov 2017.
Ends/Monday, Mar 19, 2018
Issued at HKT 15:00
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