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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Recall Number D-1156-2014
Classification Class I
Code Info All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07222013@19, 07222013@22, 07222013@23, 07222013@24, Exp 10/20/13; 07232013@1, 07232013@2, 07232013@3, 07232013@5, Exp 10/21/13; 07252013@1, 07252013@3, 07252013@4, 07252013@5, Exp 10/23/13; 07302013@24, 07302013@28, 07302013@30, 07302013@31, 07302013@32, Exp 10/28/13; 08052013@4, 08052013@6, 08052013@7, 08052013@8, 08052013@9, 08052013@10, Exp 11/03/13; 08092013@1, 08092013@8, 08092013@3, 08092013@4, 08092013@5, 08092013@6, Exp 11/07/13; 08122013@1, 08122013@3, 08122013@4, 08122013@5, 08122013@6, 08122013@7, Exp 11/10/13; 08162013@1, 08162013@3, 08162013@4, Exp 11/14/13; 08192013@2, 08192013@4, Exp 11/17/13
Product Distributed Qty 1000 vials
Reason For Recall Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Event Detail

Event Id 67214
Product Type Drugs
Status Ongoing
Recalling Firm Specialty Medicine Compounding Pharmacy, P.C.
City South Lyon
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-19
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Hospitals, clinics, physicians, and patients in the Michigan area only.
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