Class III · Low risk Ongoing
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc…
Reason Labeling: Missing Label
Is Carnitine recalled?
65 FDA recalls mention Carnitine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carnitine.
Class II · Moderate risk Ongoing
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
L-Carnitine 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 Ongoing
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Completed
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-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
MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca…
Reason Lack of Assurance of Sterility
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
S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10
Reason Lack of Assurance of Sterility
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 II · Moderate risk Ongoing
Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL…
Reason Lack of Assurance of Sterility
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