The U.S. Food and Drug Administration 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.
FDA conducted a for-cause inspection of United Pharmacy in response to the reported adverse events. During the inspection, FDA collected and analyzed samples of the GAC injectable product from two available lots: GAC-12 and GAC-13. The label for one of those samples states: “Inject 1 mL on an insulin syringe every other day in the morning subcutaneously.” FDA found the samples to have a pH of 10.9. In addition, United Pharmacy’s formula worksheets for GAC injectable products have an acceptance criteria for pH ranging from acidic (pH: 2) to basic (pH: 11).
Further, FDA found the samples did not contain any amount of glutamine. The labels of the GAC injectable samples indicate that 10 mg/mL of glutamine, 100 mg/mL of arginine, and 200 mg/mL of carnitine are contained in 30 mL vials.
United Pharmacy recalled lots GAC-12 and GAC-13 on September 27, 2017.
For more information, please visit: United Pharmacy. |
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