FDAFDA · Food and drugs·Recall number D-0255-2017
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Published January 11, 2017 · Recall initiated: November 17, 2016
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Tri-Coast Pharmacy
- Distributor
- Nationwide
- Lot
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 09212016A (01/31/2017), 08032016C (01/31/2017).
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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