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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Recall Number D-1051-2013
Classification Class II
Code Info LOT # 130617-10, Exp 12/14/2013
Product Distributed Qty 6130 mL
Reason For Recall 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.

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