FDA MedWatch - Seven Compounded Products by Olympia Pharmacy

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TOPIC: Seven Compounded Products by Olympia Pharmacy: Recall - Due to Being Out-of-Specification

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Olympia Pharmacy is recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables because these compounded products were found to be out-of-specification.

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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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. 

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Patients and health clinics that have any of the listed compounded products which are being recalled should stop using and return to Olympia Pharmacy.
• Consumers with questions regarding this recall can contact the company.
• Olympia Pharmacy is arranging for return and replacement of all recalled compounded products.

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