FDA-Drug2013-10-09Class II
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.
Triangle Compounding
Hazard
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.
Sold states
NC
Affected count
54 Vials
Manufactured in
3700 Regency Pkwy Ste 140, Cary, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1068-2013Don't want to check this manually?
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