Compounding pharmacy Pallimed Solutions Inc., of Woburn, Mass., issued a voluntary recall on Monday of sterile compounding products after “foreign matter” was found in some drug vials.
The contamination was discovered during an unannounced inspection by state and federal officials, the Associated Press (AP) reports. The firm was ordered by the state board of pharmacy to stop all sterile compounding until further notice.
The Massachusetts Department of Public Health requested the recall after Friday’s joint inspection by the state pharmacy board and the U.S. Food and Drug Administration (FDA). Most of the recalled items were used to prepare injectible erectile dysfunction treatments for patients who have difficulty taking oral medication. The company said fewer than 800 patients were involved, according to the AP. To date, the state has said there have been no reports of any patient harm. In November, Pallimed was temporarily ordered to stop production of sildenafil citrate — the active ingredient in Viagra — after inspectors found the firm had been using improper components. The company said those issues had been resolved, and that Monday’s announcement was unrelated.
Compounding pharmacies in a number of states have been under scrutiny in recent months. A deadly outbreak of fungal meningitis was traced to contaminated steroid injections produced at the New England Compounding Center. More than 700 people became ill and 50 died because of the tainted injections, according to the Centers for Disease Control and Prevention (CDC). In recent weeks, compounders in Georgia and New Jersey have recalled products because of contamination and concerns about the safety of sterile products. Health officials have called on the FDA to tighten regulations for compounding pharmacies.