Class II · Moderate risk Ongoing
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Is Pyridoxine recalled?
72 FDA recalls mention Pyridoxine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pyridoxine.
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 Terminated
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset…
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile…
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured…
Reason Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II · Moderate risk Terminated
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/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
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0955-30
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0956-30
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
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