FDA recall D-0255-2017

Product

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

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2016-11-17

Report date

2017-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Juno Beach, FL, United States

Primary source

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