FDA recall D-191-2013

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-22

Report date

2013-03-20

Termination date

2013-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chester, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-191-2013