Class II · Moderate risk Terminated
Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
Reason Lack of Assurance of Sterility
Is Arginine recalled?
36 FDA recalls mention Arginine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Arginine.
Class II · Moderate risk Terminated
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Class II · Moderate risk Ongoing
Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Ongoing
L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Terminated
L-Arginine 100mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Class II · Moderate risk Terminated
L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS)
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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