FDA-Drug2017-01-11Class II

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.

Tri-Coast Pharmacy
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide
Affected count
10 vials
Manufactured in
14125 US Highway 1, N/A, Juno Beach, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2017

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