Class II · Moderate risk Ongoing
Calm Me
Reason Lack of Assurance of Sterility
L-Tryptophan Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Recalling firm
- Downing Labs, LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0339-2016
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 Tryptophan recalls
See all
Class II · Moderate risk Terminated
Tryptophan 10mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
L-Tryptophan 300 Mg/Ml Injectable
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk Terminated
L-Tryptophan 15mg/Ml Injectable 60 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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