Recall Enforment Report D-1068-2013
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Triangle Compounding, originally initiated on 09-06-2013 for the 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. The product was recalled due to 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 product was distributed in Nc and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1068-2013 | 09-06-2013 | 10-09-2013 | Class II | 54 Vials | 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. | 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. | Terminated |
| D-1069-2013 | 09-06-2013 | 10-09-2013 | Class II | 8 vials | Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. | 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. | Terminated |
