Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

On March 10, 2022, FDA announced that specific lots of seven of Olympia Pharmacy’s compounded injectable products were found to be out-of-specification. Olympia Pharmacy is voluntarily recalling 11 specific lots of the seven compounded injectables, including Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD.

There have not been any reports, concerns or adverse effects from patients relating to the safety of the recalled compounded products. The products being recalled are typically prescribed for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder.

The FDA Risk Statement reads as follows: “Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.”

Source: FDA