RecallDepth
Class II Terminated

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.

Company
Triangle Compounding
Recall Initiated
September 6, 2013
Posted
October 9, 2013
Recall Number
D-1068-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
54 Vials
Firm Location
Cary, NC, United States

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

NC

Lot / Code Info

Lot #814748-LG14917, Exp 10/31/13

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