Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Fa...
Reason: Lack of Assurance of Sterility
D-0362-2023March 8, 2023West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Fa...
Reason: Lack of Assurance of Sterility
D-0356-2023March 8, 2023West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 450...
Reason: Lack of Assurance of Sterility
D-0355-2023March 8, 2023West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcin...
Reason: Lack of Assurance of Sterility
D-0358-2023March 8, 2023West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing...
Reason: Lack of Assurance of Sterility
D-0357-2023March 8, 2023West Columbia, SC
B. Braun Medical Inc.
Class IICompleted
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reason: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal t...
D-0346-2023March 1, 2023Daytona Beach, FL
B. Braun Medical Inc.
Class IICompleted
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Reason: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal t...
D-0347-2023March 1, 2023Daytona Beach, FL
Sentara Infusion Services
Class IITerminated
MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 30...
Reason: Lack of sterility assurance
D-0303-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0274-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0281-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
Reason: Lack of sterility assurance
D-0297-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0293-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0288-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0283-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0290-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 53...
Reason: Lack of sterility assurance
D-0278-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0311-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Ph...
Reason: Lack of sterility assurance
D-0316-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0284-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0310-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0305-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0298-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Ho...
Reason: Lack of sterility assurance
D-0296-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Indepen...
Reason: Lack of sterility assurance
D-0272-2023February 22, 2023Chesapeake, VA
Sentara Infusion Services
Class IITerminated
LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320