Northern VA Compounders PLLC FDA Recalls

25 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Related datasets

FDA ApprovalsNew drugs approved, and devices cleared for sale.Workplace SafetyOSHA inspections and citations, by company.Congress TradingThe live feed of disclosed transactions.Politician SearchEvery member who files, and what they hold.

Product	Reason	Class	Initiated
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mLClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL MultiplClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, CompouClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 234Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL MultiClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged iClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL MultipClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, RClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials,Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, RxClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, RClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 234Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-DClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, RClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina PharmClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-DClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vialClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged iClass IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2Class IIDec 30, 2022Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	Dec 30, 2022