D-191-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2013
- Initiation Date
- January 22, 2013
- Termination Date
- March 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 vials
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.
Reason for Recall
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Distribution Pattern
Nationwide
Code Information
Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13