Thursday, November 19, 2015

Compounded Veterinary Drugs on FDA November 18, 2015 Enforcement Report

VeterinaryCyclosporin drops, ophthalmic 1%, solution, Rx only, compounded by Moses Lake Pharmacy.t09242014@14; t10062014@3; t10062014@29; t02032015@22; t06252015@29;Class IIThe firm is recalling Cyclosporin drops, ophthalmic 1% due to lack of sterility assuranceJD & SN Inc., dba Moses Lake Professional Pharmacy
VeterinaryBuprenorphine, multidose sterile vial, 03.mg/mL, injectable solution, Rx only, compounded by Moses Lake Pharmacy.t03242015@21 and t06112015@37Class IIThe firm is recalling Buprenorphine, injectable solution, due to lack of sterility assuranceJD & SN Inc., dba Moses Lake Professional Pharmacy
VeterinaryMisoprostol (F.O.B.) 2 mg/5 mL oral Suspension NDC: 22200899801; Misoprostol (F.O.B) 1.4 mg/10 mL Suspension NDC: 22200894701.03182015@32, 03312015@36, 04162015@5, 05082015@3, 07072015@67, 03262015@38Class IIFirm determined that formulation was developed with the intent of using an active pharmaceutical ingredient with a potency of greater than or equal 99%. However, the active pharmaceutical ingredient used in the formulation acquired from the supplier was a 1% diluted product rendering the finished product as sub-potent.US Compounding Inc
VeterinaryMisoprostol 30 mL 1.4 mg/10 mL Paste NDC: 22200894630; Misoprostol 30 mL 1.4 mg/mL Paste NDC: 22200880730; Misoprostol 60 mL 1.4 mg/10 mL Paste NDC: 22200893660; Misoprostol 60 mL 1.6 mg/30 mL Paste NDC: 22200579460; Misoprostol 60 mL 1.6 mg/5 mL Paste NDC: 2220061726003042015@1, 03232015@11, 03262015@1, 06102015@64, 01062015@30, 01082015@41, 02202015@44, 04242015@52, 02262015@1, 04022015@33, 04072015@3, 06092015@30, 06102015@4, 07062015@1, 07132015@65, 01222015@23, 01222015@25, 01282015@12, 02182015@39, 03232015@23Class IIFirm determined that formulation was developed with the intent of using an active pharmaceutical ingredient with a potency of greater than or equal 99%. However, the active pharmaceutical ingredient used in the formulation acquired from the supplier was a 1% diluted product rendering the finished product as sub-potent.US Compounding Inc