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,
FDA recall notice · announced March 20, 2013 · Rx South Llc Dba Rx3 Pharmacy
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Notes
Distribution: Nationwide
Lot/code information: Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Quantity: 126 vials
Status: Terminated
Products in this recall event:
- 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, Rx (D-191-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.