Home / Recalls / Compounding Centre At Blue Ridge / D-403-2014

D-403-2014 Class II Terminated

Recalled by Compounding Centre At Blue Ridge — Raleigh, NC

Recall Details

Product Type
Drugs
Report Date
January 15, 2014
Initiation Date
October 18, 2013
Termination Date
April 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 Vials

Product Description

Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

Reason for Recall

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Distribution Pattern

NC

Code Information

All Lots

Other recalls by Compounding Centre At Blue Ridge

  • D-404-2014 Class II — Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 B (October 18, 2013)
  • D-401-2014 Class II — Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Benn (October 18, 2013)
  • D-402-2014 Class II — PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compoundi (October 18, 2013)
  • D-405-2014 Class II — Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compound (October 18, 2013)