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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64541
Product Type Drugs
Status Ongoing
Recalling Firm RX South LLC DBA RX3 Pharmacy
City Chester
State VA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13 Class II CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. 126 vials D-191-2013