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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66172
Product Type Drugs
Status Ongoing
Recalling Firm Medaus, Inc.
City Birmingham
State AL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-23
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 LOT # 130613-8, Exp 12/10/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 8750 mL D-1055-2013
NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130702-1, Exp 12/29/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 15,500 mL D-1054-2013
Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130307-60, Exp 9/3/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 1880 mL D-1053-2013
Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130531-31, Exp 11/27/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 2970 mL D-1052-2013
L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130617-10, Exp 12/14/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 6130 mL D-1051-2013
Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 LOT # 130618-64, BUD: 12/15/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 1660 mL D-1050-2013
Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183 Lot #: 130510-26, Exp 11/16/2013; 130610-24, Exp 12/7/2013; and 130709-68, Exp 1/5/2014 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 19,803 mL D-1049-2013
Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183 LOT # 130508-1, BUD: 11/16/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. 1198 mL D-1048-2013
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