For Immediate Release
September 6, 2018
Matt White, Pharm. D.
SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.
Administration of a drug product that may contain precipitate has the potential to result in serious adverse events due to dosages that may be lower than intended and could lead to therapeutic failures. Intravenous administration of a product with the precipitate can result in blockage of blood vessels and/or catheter occlusions which could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to permanent lung damage.
SCA Pharmaceuticals has received one (1) customer complaint reporting the presence of precipitate. To date, no adverse events have been reported. Conservatively, the firm is voluntarily recalling seven (7) lots of the same product that are within their Beyond Use Date. These lots are listed in the table below: (more…)