January 2013 FDA Recall Drug by Rx South Llc Dba Rx3 Pharmacy
D-191-2013 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Rx South Llc Dba Rx3 Pharmacy on January 22, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-191-2013

Reason for Recall
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Initiated
01-22-2013
Reported
03-20-2013
Quantity
126 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64541
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RX South LLC DBA RX3 Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-25-2013
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13