FDA Investigates Two Adverse Events Associated With Compounded Injectable Drugs – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
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, FL. According to the report, a sample of the product was sent for testing and the pH was determined to be above 11.
In response to the reported adverse events, 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. 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. A compounding risk alert indicates United Pharmacy recalled lots GAC-12 and GAC-13 on September 27, 2017.
Compounding pharmacies should be aware of safety information related to the physical and chemical attributes of their injectable products, including pH. Because compounded products are not evaluated by FDA for safety and effectiveness, health care professionals should query the compounding pharmacy about the safety information related to the physical and chemical attributes of the compounded products they plan to inject into patients.