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ISSUE: 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.
Compounded drugs have not been evaluated by FDA for safety, effectiveness, and quality. There is no FDA-approved injectable GAC product.
BACKGROUND: United Pharmacy recalled lots GAC-12 and GAC-13 on September 27, 2017.
RECOMMENDATION: Compounding pharmacies should be aware of saf...