FDA Discovers Oklahoma Facility Producing Banned Drug
The Apothecary Shoppe’s facility in Oklahoma has been given a warning letter after an FDA inspection revealed that the firm produces potassium chloride, a drug that appears on the list of drug products that have been withdrawn or removed from the market.
In addition to the banned substance, the investigators also discovered products made from domperidone. That chemical that is not the subject of an applicable United States Pharmacopeia or National Formulary monograph, and isn’t a component of a FDA-approved human drug product.
Additionally, investigators discovered serious deficiencies in the firm’s practices in producing sterile drug products, including its lack of sterile wipes or a sporicidal agent as part of the disinfection program for the ISO 5 laminar hoods and ISO 7 cleanroom where sterile drug products are prepared.