Olympia Pharmacy has issued a voluntary nationwide recall of seven compounded products due to being out-of-specification. The voluntary recall is for 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level.
Risk Statement: 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.
Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.
Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.