Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 5% MDV Injection
Reason Lack of assurance of sterility.
Sodium Tetradecyl Sulfate 5% Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What was recalled
Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1635-2015
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.
Other Tetradecyl recalls
See all
Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 1.5% MDV Injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 0.3% Injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
Sodium Tetradecyl Sulfate
Reason Lack of Assurance of Sterility
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