The Recall Desk

FDA (Drugs) recall action 66297

Triangle Compounding recalled 2 products on 2013-10-09

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-10-09
Critical
0
Units
62

Why these products were recalled

Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

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

1–2 of 2

  • SevereFDA (Drugs)··2013-10-09

    Triangle Compounding Recalls Sodium Phosphate Injectable Due to Sterility Concerns

    Triangle Compounding is recalling 54 vials of Sodium Phosphate Injectable because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-10-09

    Triangle Compounding Recalls Histamine Injectable Due to Sterility Concerns

    Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Distribution
    1 state