Reported Oct 9, 2013 · Terminated
Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle…
Triangle Compounding
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Triangle Compounding · 3700 Regency Pkwy Ste 140 · Cary, NC · 27518-8696
Is this the product you have?
Sodium Phosphate Injectable150mM/50mL Phosphorus 200mEq/50mL Sodium50 mL Single Dose VialRx onlyTriangle Compounding Pharmacy3700 Regency ParkwaySuite 140Cary NC 27518
- Lot codes and dates
Lot #814748-LG14917Exp 10/31/13
- Amount recalled
- 54 Vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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