Class II · Moderate risk Ongoing
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Is Arginine recalled?
36 FDA recalls mention Arginine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Arginine.
Class II · Moderate risk Ongoing
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate…
Reason Super Potent and Failed Reconstitution Time
Class II · Moderate risk Ongoing
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B…
Reason Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk Terminated
Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded…
Reason CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class I · High risk Terminated
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg…
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class II · Moderate risk Ongoing
Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
Reason Lack of Assurance of Sterility
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