CLASS II Drug recall · Reported 20 Mar 2013 · FDA Enforcement Report
Medi-bolic Booster Injectable (methionine 8.3 mg/mL recalled by RX South
RX South is recalling Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, distributed nationwide in the US. The recall was initiated on 22 Jan 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-191-2013
- FDA event ID
- 64541
- Recalling firm
- RX South, Chester, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2013
- FDA classified
- 8 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jan 2013 | Recall initiated by company | |
| 8 Mar 2013 | Classified by FDA | +45 days |
| 20 Mar 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Which lots are affected?
Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RX South
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxyprogesterone Caproate 250mg/ml recalled by RX South | RX South | Temperature Abuse | MD, VA |