US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 6, 2013 (13 years ago)

Sodium Phosphate Injectable

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

What was recalled

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.

Recalling firm
Triangle Compounding
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1068-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Class II · Moderate risk Terminated

ZTE-1035 Formula

Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Washington Homeopathic Products, Inc. D-0886-2021
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Aminosyn 3.5% M Sulfite-Free

Reason Lack of Assurance of Sterility; potential leakage from administrative port.

Hospira Inc. D-1035-2014
Class II · Moderate risk Terminated

CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet

Reason Labeling: Label Mixup; CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet, 120 units/105 mg/81 mg may be potentially mislabeled as PROMETHAZINE HCL, Tablet, 25 mg, NDC 65162052110, Pedigree: W002578, EXP: 6/3/2014; VALSARTAN, Tablet, 40 mg, NDC 00078042315, Pedigree: AD32579_1, EXP: 5/9/2014.

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Class II · Moderate risk Terminated

PHOSPHORUS Tablet

Reason Labeling: Label Mixup; PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: AD56921_1, EXP: 5/21/2014; VENLAFAXINE HCL, Tablet, 75 mg, NDC 00093738201, Pedigree: W002533, EXP: 2/28/2014; NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg, NDC 47781030701, Pedigree: AD25452_4, EXP: 5/3/2014; traZODone HCl, Tablet, 50 mg, NDC 50111043303, P

Aidapak Services, LLC D-699-2014