Class II · Moderate risk
Calm Me (Aminobutyric Acid (GABA)
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
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
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
Drug: Tryptophan
- Recalling firm
- Downing Labs, LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0339-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tryptophan recalls
See all
Class II · Moderate risk
Tryptophan 10mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
L-Tryptophan 300 Mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
L-Tryptophan 15mg/Ml Injectable 60 Ml
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.
Other recalls by Downing Labs, LLC
All 2015 recalls
Class II · Moderate risk
Methylcobalamin Injection Buffered 5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
MIC w/Methyl B-12 Preserved Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Thiotic Acid Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Magnesium Sulfate Injection
Lack of Assurance of Sterility
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.