Class II · Moderate risk Ongoing
B5 Dexpanthenol 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 Dexpanthenol recalled?
43 FDA recalls mention Dexpanthenol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dexpanthenol.
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
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 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
Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC…
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701…
Reason Lack of Assurance of Sterility
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.
Class II · Moderate risk Terminated
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED…
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromiu…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La…
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100…
Reason Lack of Assurance of Sterility
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