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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 64640
Product Type Drugs
Status Ongoing
Recalling Firm Med Prep Consulting, Inc.
City Tinton Falls
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-14
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 All lots Class I Non-Sterility; mold contamination 403883 bags D-810-2013
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 All lots Class II Lack of Assurance of Sterility; potential for mold contamination D-811-2013
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