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.
Is Niacin recalled?
48 FDA recalls mention Niacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Niacin.
Class II · Moderate risk Terminated
METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%, Clindamycin 1%), Rx only, Synergy RX, 4901…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Ongoing
Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg +…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium…
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk Terminated
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960…
Reason Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class II · Moderate risk Terminated
NIACIN TR, Tablet, 1000 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703801.
Reason Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 750 mg, NDC…
Class II · Moderate risk Terminated
NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703301.
Reason Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the following drug: NORTRIPTYLINE HCL, Capsule, 50 mg, NDC…
Class II · Moderate risk Terminated
NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
Reason Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000…
Class II · Moderate risk Terminated
NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
Reason Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree…
Class II · Moderate risk Terminated
NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
Reason Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968…
Class II · Moderate risk Terminated
NIACIN, Tablet, 500 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227260.
Reason Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC…
Class II · Moderate risk Terminated
NIACIN, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227160.
Reason Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC…
Class II · Moderate risk Terminated
NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
Reason Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg…
Class II · Moderate risk Terminated
NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
Reason Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2…
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