FDA (Drugs) recall action 71618
The FDA (Drugs) publishes a recall like this one as 28 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 28 pages.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..
The agency’s own wording, quoted from the enforcement report.
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Phentolamine 5 mg/mL vials in Oklahoma due to lack of documentation for environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Papaverine 30 mg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.