Class II · Moderate risk Completed
Sodium Tetradecyl Sulfate 5% MDV Injection
Reason Lack of assurance of sterility.
Sodium tetradecyl sulfate 5%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
What was recalled
Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0136-2015
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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