FDA recall D-1068-2013

Triangle Compounding · Class II · drug

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.

Reason for recall

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.

Distribution

Key facts

Status: Terminated
Initiation date: 2013-09-06
Report date: 2013-10-09
Termination date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1068-2013