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# Adverse Reports from United Pharmacy Injectable
- URL: https://www.fdaweb.com/adverse-reports-from-united-pharmacy-injectable/
- Published: 2017-11-08T12:00:00.000Z
- Updated: 2026-09-14T23:00:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140086

FDA [says](https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm584125.htm?utm%5Fcampaign=FDA%20investigates%20two%20adverse%20events%20associated%20with%20United%20Pharmacy%E2%80%99s%20compounded&utm%5Fmedium=email&utm%5Fsource=Eloqua) it has received an adverse event report that two patients developed tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, West Palm Beach, FL. The adverse event report indicated that a sample of the product was tested and found to have a pH above 11.

The agency says it conducted a for-cause inspection of United Pharmacy and collected two samples of GAC that were analyzed and found to have pH of 10.9 with no glutamine detected.

“Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences,” the FDA notice says. The company recalled two available GAC lots 9/27.

The notice points out that compounded drugs have not been evaluated by FDA for safety, effectiveness, and quality, and says there is no FDA-approved injectable GAC product. It says the agency investigation into the United Pharmacy GAC adverse events highlights some of the risks associated with compounded drugs that do not undergo FDA premarket review, including: 

- the product specifications used by compounding facilities, such as pH, and the pH of the compounded drug are not evaluated by FDA for safety;
- the subcutaneous administration of an injectable product with an alkaline pH could result in skin damage or other unintended health consequences; and
- the ingredients listed on the labeling of a compounded product may not accurately reflect the ingredients contained within the product.

“Compounding pharmacies should be aware of safety information related to the physical and chemical attributes of their injectable products, including pH,” the notice says. “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.”