Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4...
Reason: Lack of Assurance of Sterility
D-1271-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 450...
Reason: Lack of Assurance of Sterility
D-1274-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500...
Reason: Lack of Assurance of Sterility
D-1276-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12...
Reason: Lack of Assurance of Sterility
D-1254-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St...
Reason: Lack of Assurance of Sterility
D-1262-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500...
Reason: Lack of Assurance of Sterility
D-1275-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Co...
Reason: Lack of Assurance of Sterility
D-1273-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facilit...
Reason: Lack of Assurance of Sterility
D-1281-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th S...
Reason: Lack of Assurance of Sterility
D-1260-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12...
Reason: Lack of Assurance of Sterility
D-1265-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, 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 S...
Reason: Lack of Assurance of Sterility
D-1277-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing f...
Reason: Lack of Assurance of Sterility
D-1279-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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-1267-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Stree...
Reason: Lack of Assurance of Sterility
D-1255-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Ext...
Reason: Lack of Assurance of Sterility
D-1250-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 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-1251-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 50...
Reason: Lack of Assurance of Sterility
D-1248-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC:...
Reason: Lack of Assurance of Sterility
D-1269-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, Wes...
Reason: Lack of Assurance of Sterility
D-1252-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th S...
Reason: Lack of Assurance of Sterility
D-1261-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x ...
Reason: Lack of Assurance of Sterility
D-1278-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12...
Reason: Lack of Assurance of Sterility
D-1266-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Exten...
Reason: Lack of Assurance of Sterility
D-1257-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 ...
Reason: Lack of Assurance of Sterility
D-1258-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4...