Compounded Injectables Recalled

United Pharmacy has recalled two lots of a compounded injectable glutamine/arginine/carnitine product. The FDA received two adverse event reports of two patients who developed tissue erosion at the injection site.

The lots are GAC-12 and GAC-13 and they were recalled on September 27, 2017. United Pharmacy is located in West Palm Beach, FL.

Both patients experienced what is described in the report as tissue erosion at the injection site following administration of GAC.

According to the FDA report, a sample of the product was sent for testing. The lab found that the pH was above 11. Injectable drugs with a high pH may cause skin damage or other unintended health consequences. The FDA then 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. A parenteral product with a pH above 9 can cause tissue necrosis, according to the FDA.

The samples were labeled as containing 10 mg/mL of glutamine, 100 mg/mL of arginine, and 200 mg/mL of carnitine in 30 mL vials.

The FDA noted that there is no FDA-approved injectable glutamine/arginine/carnitine product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178