FDA recall D-0323-2017

Tri-Coast Pharmacy · Class II · drug

Product

Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 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-0323-2017