Drug & medication recalls Moderate risk

Tri-Coast Pharmacy product recalled over sterility concerns

Recall date
November 17, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Tri-Coast Pharmacy recalls Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/…
Recall number
D-0255-2017
FDA classification
Class II
Brand / firm
Tri-Coast Pharmacy
Sold / distributed
Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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