Drug recall
Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL…
FDA recall event 64541 · Class II · RX South LLC DBA RX3 Pharmacy
Key facts
| Event ID | 64541 |
|---|---|
| Recall numbers | D-191-2013 |
| Recalling firm | RX South LLC DBA RX3 Pharmacy |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures. |
| Initiation date | Jan 22, 2013 |
| Report date | Mar 20, 2013 |
| Termination date | Mar 25, 2013 |
| City | Chester |
| State | VA |
| Country | United States |
| FEI number | 3008723337 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: