Enforcement Report - Week of March 20, 2013
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | D-191-2013 |
| Classification | Class II |
| Code Info | Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13 |
| Product Distributed Qty | 126 vials |
| Reason For Recall | CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. |
Event Detail
| Event Id | 64541 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | RX South LLC DBA RX3 Pharmacy |
| City | Chester |
| State | VA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
-
