PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: January 11, 2017 Initiated: November 17, 2016 #D-0255-2017

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Tri-Coast Pharmacy
Units Affected
10 vials
Distribution
Nationwide
Location
Juno Beach, FL

Frequently Asked Questions

What product 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.. Recalled by Tri-Coast Pharmacy. Units affected: 10 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2017. Severity: Moderate. Recall number: D-0255-2017.