Status
Terminated
Drug Enforcement D-191-2013
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Classification
Class II
Report Date
March 20, 2013
Termination Date
March 25, 2013
Product Information
- 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.
- Product quantity
- 126 vials
- Reason for recall
- CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- RX South LLC DBA RX3 Pharmacy
- Address
-
12230 Iron Bridge Rd, Ste. C
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-191-2013
- Event ID
- 64541
- Recall initiation date
- January 22, 2013
- Center classification date
- March 8, 2013
- Code info
- Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
- More code info
- —