FDA recall D-0321-2017

Product

Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + 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-0321-2017