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- Recall Enforcement Event ID: 91443
Recall Enforment Report D-0110-2023
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Northern VA Compounders PLLC, originally initiated on 12-30-2022 for the product 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. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0110-2023 | 12-30-2022 | 01-18-2023 | Class II | 4 vials | 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. | Lack of Assurance of Sterility | Terminated |
D-0112-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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. | Lack of Assurance of Sterility | Terminated |
D-0114-2023 | 12-30-2022 | 01-18-2023 | Class II | 4 vials | 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, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0103-2023 | 12-30-2022 | 01-18-2023 | Class II | 78 vials | 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 Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0126-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0121-2023 | 12-30-2022 | 01-18-2023 | Class II | 8 vials | 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, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0109-2023 | 12-30-2022 | 01-18-2023 | Class II | 4 vials | 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. | Lack of Assurance of Sterility | Terminated |
D-0102-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0123-2023 | 12-30-2022 | 01-18-2023 | Class II | 36 vials | 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 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0122-2023 | 12-30-2022 | 01-18-2023 | Class II | 4 vials | 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, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0125-2023 | 12-30-2022 | 01-18-2023 | Class II | 1200 vials | BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0115-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0117-2023 | 12-30-2022 | 01-18-2023 | Class II | 525 vials | 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, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0116-2023 | 12-30-2022 | 01-18-2023 | Class II | 4 vials | 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, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0111-2023 | 12-30-2022 | 01-18-2023 | Class II | 108 vials | Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0105-2023 | 12-30-2022 | 01-18-2023 | Class II | 56 vials | 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 Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0118-2023 | 12-30-2022 | 01-18-2023 | Class II | 8 vials | 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 Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0106-2023 | 12-30-2022 | 01-18-2023 | Class II | 750 vials | 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 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0113-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0107-2023 | 12-30-2022 | 01-18-2023 | Class II | 39 vials | QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0119-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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. | Lack of Assurance of Sterility | Terminated |
D-0124-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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 Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0120-2023 | 12-30-2022 | 01-18-2023 | Class II | 2 vials | 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 Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0108-2023 | 12-30-2022 | 01-18-2023 | Class II | 6 vials | QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |
D-0104-2023 | 12-30-2022 | 01-18-2023 | Class II | 12 vials | 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 Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Terminated |