Class II · Moderate risk Terminated Feb 9, 2018 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC… Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure… American Pharmaceutical Ingredients LLC NDC 58597-8525-3 D-0520-2018
Class II · Moderate risk Terminated Oct 7, 2015 Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Pacific Healthcare, Inc dba B&B Pharmacy D-0165-2016
Class II · Moderate risk Ongoing May 29, 2013 Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-783-2013