Class II · Moderate risk Terminated
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05)…
Reason Lack of Assurance of Sterility
Is Choline recalled?
151 FDA recalls mention Choline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Choline.
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
(WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, Rx only…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E…
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only…
Reason Lack of processing controls
Class III · Low risk Terminated
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC…
Reason Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage…
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class III · Low risk Terminated
Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR…
Reason Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making…
Class II · Moderate risk Terminated
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland…
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk Terminated
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose…
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled…
Reason Incorrect labeling: Incorrect or missing lot and/or exp date
Class II · Moderate risk Terminated
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only…
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
SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per vial, RXQ Compounding, 340 West State…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Class II · Moderate risk Terminated
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable…
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.
Class II · Moderate risk Terminated
Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding…
Reason Lack of sterility assurance.
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