Class II · Moderate risk Ongoing
Calm Me
Reason Lack of Assurance of Sterility
L-Tryptophan 15mg/Ml Injectable 60 Ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1567-2012
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 Injectable
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
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.