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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description 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.
Recall Number D-191-2013
Classification Class II
Code Info Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Product Distributed Qty 126 vials
Reason For Recall CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.

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 Letter
Distribution Pattern Nationwide