Specialty Compounding Llc has reached a settlement with the U.S. FDA, barring the company from producing and selling sterile drugs until it receives written approval from the agency.
Specifically, the U.S. District Court for the Western District of Texas entered a consent decree of permanent injunction against Cedar Park-based Specialty Compounding and co-owners, Raymond L. Solano III and William L. Swail, to prevent the distribution of adulterated and misbranded drugs.
In August, 2013, the FDA issued a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding after reports of bacterial bloodstream infections related to the company's calcium gluconate infusions.
Specialty Compounding ceased sterile drug manufacturing operations in August 2013 and now has settled litigation without an admission of guilt, but cannot reopen until upgrades are made and the FDA deems the facility safe for manufacturing sterile products.
Read the Reuters press release