Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 5% MDV Injection
Reason Lack of assurance of sterility.
Sodium Tetradecyl SO4 0.3% Inj.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
What was recalled
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
- Recalling firm
- Perry Drug Inc.
- NDC code
- 88888-6427-90
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0275-2015
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 5% Injectable
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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