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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 65125
Product Type Drugs
Status Ongoing
Recalling Firm THE COMPOUNDING SHOP, INC.
City St Petersburg
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Florida, California, Minnesota, and Maine

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 80 vials of 4mL each D-549-2013
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 19 vials of 10ml D-548-2013
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 78 vials of 500ml and 92 vials of 100mL D-563-2013
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 2 vials of 250mL and 26 vials of 100mL D-562-2013
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 44 vials of 50mL each D-561-2013
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 4 vials of 10mL each D-560-2013
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 55 vials of 100mL D-559-2013
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 7 vials of 50mL each D-558-2013
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 43 vials of 250mL each D-557-2013
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL D-556-2013
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 41 vials of 2mL D-555-2013
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 2 vials of 100mL D-554-2013
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 20 vials of 5mL D-553-2013
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 3 vials of 45mL D-552-2013
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 56 vials of 50mL D-564-2013
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 vial of 20mL and 1 vial of 40mL D-551-2013
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. 1 vial of 22mL D-550-2013
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 4 vials of 5mL and 22 vials of 10mL D-572-2013
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 10 vials of 30 mL each D-571-2013
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 5 vials of 50mL D-570-2013
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 1 vial of 40ml D-569-2013
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 1 vial of 40mL D-568-2013
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL D-567-2013
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 14 vials of 30mL each D-566-2013
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes 32 vials of 50mL D-565-2013
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