Why it was recalled
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
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.
Lot numbers, UPCs & expiration codes
Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-191-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 22, 2013
- FDA report date
- Mar 20, 2013
- Quantity
- 126 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RX South LLC DBA RX3 Pharmacy
Original FDA data
Every field from FDA enforcement report D-191-2013, exactly as published.
Show all FDA fields
- City
- Chester
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 64541
- Address
- 12230 Iron Bridge Rd
- Address (line 2)
- Ste. C
- Code information
- Lot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
- Postal code
- 23831-1534
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-191-2013
- Classification
- Class II
- Recalling firm
- RX South LLC DBA RX3 Pharmacy
- Product quantity
- 126 vials
- Termination date
- Mar 25, 2013
- Reason for recall
- CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2013