Safety Report: Olympia Pharmacy Compounded Injectables - recalled due to products are out of specification, USA

United States

Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.

The affected lots include the following lot numbers and expiration dates listed below. The product can be identified by reading the lot number in the black strike zone of the label and was distributed to patients and health clinics.

Olympia Pharmacy is notifying its customers by mail and is arranging for return and replacement of all recalled compounded products. Patients and health clinics that have any of the listed compounded products which are being recalled should stop using and return to Olympia Pharmacy.

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. The compounded products being recalled are typically prescribed by medical professionals for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder.

Company name: Olympia Pharmacy
Brand name: Olympia Pharmaceuticals
Product recalled: Compounded Injectables
Reason of the recall: Products are out of specification
FDA Recall date: March 10, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympia-pharmacy-issues-voluntary-nationwide-recall-seven-compounded-products-due-being-out

Source: FDA