Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0109-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0112-2023January 18, 2023Sterling, VA
Nephron Sterile Compounding Center LLC
Class IITerminated
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172,...
Reason: Lack of Assurance of Sterility
D-0099-2023January 18, 2023West Columbia, SC
Northern VA Compounders PLLC
Class IITerminated
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 10...
Reason: Lack of Assurance of Sterility
D-0123-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Sui...
Reason: Lack of Assurance of Sterility
D-0120-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suit...
Reason: Lack of Assurance of Sterility
D-0118-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock...
Reason: Lack of Assurance of Sterility
D-0104-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling,...
Reason: Lack of Assurance of Sterility
D-0113-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling,...
Reason: Lack of Assurance of Sterility
D-0115-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterl...
Reason: Lack of Assurance of Sterility
D-0121-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, ...
Reason: Lack of Assurance of Sterility
D-0117-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0110-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling,...
Reason: Lack of Assurance of Sterility
D-0114-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling...
Reason: Lack of Assurance of Sterility
D-0116-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven W...
Reason: Lack of Assurance of Sterility
D-0103-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Ha...
Reason: Lack of Assurance of Sterility
D-0105-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0119-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite...
Reason: Lack of Assurance of Sterility
D-0106-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterlin...
Reason: Lack of Assurance of Sterility
D-0122-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 10...
Reason: Lack of Assurance of Sterility
D-0126-2023January 18, 2023Sterling, VA
Northern VA Compounders PLLC
Class IITerminated
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock H...
Reason: Lack of Assurance of Sterility
D-0124-2023January 18, 2023Sterling, VA
Pfizer Inc.
Class IICompleted
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By ...
Reason: Lack of assurance of sterility: Bags have the potential to leak.
D-0097-2023January 11, 2023New York, NY
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 0...
Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
D-0075-2023December 14, 2022Waltham, MA
B. Braun Medical, Inc.
Class IITerminated
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Reason: Lack of sterility assurance: Bags have the potential to leak.
D-0076-2023December 14, 2022Allentown, PA
ICU Medical Inc
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.