Drug product
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.
D-191-2013
Product summary
- Event
- Event 64541
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 vials
- Official record key
drug-enforcement:D-191-2013
Official wording
Reason: CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Code information: Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations