ZTE-1035 Formula
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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.
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.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Lack of Assurance of Sterility; potential leakage from administrative port.
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.
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
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