Drug Recalls

Nephron Sterile Compounding Center LLC

Class II Terminated

Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th...

Reason: Lack of Assurance of Sterility

D-1253-2022 July 27, 2022 West Columbia, SC

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1199-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1213-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1223-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1241-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1239-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1206-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1204-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1228-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1194-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1216-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1212-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1203-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1205-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1235-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1229-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1215-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1192-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1230-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1234-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1195-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1209-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1232-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1200-2022 July 20, 2022 Nicholasville, KY

TMC Acquisition LLC dba Tailor Made Compounding

Class II Ongoing

Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding

Reason: Lack of Assurance of Sterility

D-1201-2022 July 20, 2022 Nicholasville, KY

FDA Enforcement Report