Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 6517...
Reason: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
D-1189-2022July 20, 2022Kirkland
TMC Acquisition LLC dba Tailor Made Compounding
Class IIOngoing
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
D-1202-2022July 20, 2022Nicholasville, KY
TMC Acquisition LLC dba Tailor Made Compounding
Class IIOngoing
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
D-1226-2022July 20, 2022Nicholasville, KY
TMC Acquisition LLC dba Tailor Made Compounding
Class IIOngoing
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
D-1208-2022July 20, 2022Nicholasville, KY
SUN PHARMACEUTICAL INDUSTRIES INC
Class IITerminated
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutica...
Reason: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
D-1154-2022June 29, 2022Princeton, NJ
SUN PHARMACEUTICAL INDUSTRIES INC
Class IITerminated
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pha...
Reason: Lack of assurance of sterility
D-1147-2022June 22, 2022Princeton, NJ
SUN PHARMACEUTICAL INDUSTRIES INC
Class IITerminated
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, In...
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West...
Reason: Lack of Assurance of Sterility
D-0964-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 1...
Reason: Lack of Assurance of Sterility
D-0955-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension,...
Reason: Lack of Assurance of Sterility
D-0953-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext...
Reason: Lack of Assurance of Sterility
D-0959-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12...
Reason: Lack of Assurance of Sterility
D-0968-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extens...
Reason: Lack of Assurance of Sterility
D-0957-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility...
Reason: Lack of Assurance of Sterility
D-0963-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext...
Reason: Lack of Assurance of Sterility
D-0965-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ex...
Reason: Lack of Assurance of Sterility
D-0966-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12t...
Reason: Lack of Assurance of Sterility
D-0961-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension...
Reason: Lack of Assurance of Sterility
D-0952-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 45...
Reason: Lack of Assurance of Sterility
D-0962-2022June 8, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext...