The Recall Desk

FDA (Drugs) recall action 66568

Compounding Centre At Blue Ridge recalled 5 products on 2014-01-15

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2014-01-15
Critical
0
Units
107

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • SevereFDA (Drugs)··2014-01-15

    Triple Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ri
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-15

    Quad Mix Injectable Recalled Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-15

    FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

    The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

    Product
    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-15

    FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-15

    FDA Recalls PGE Injectable Due to Sterility Assurance Concerns

    The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Distribution
    1 state