D-0308-2017 Class II Ongoing

Recalled by Tri-Coast Pharmacy — Juno Beach, FL

Recall Details

Product Type
Drugs
Report Date
January 11, 2017
Initiation Date
November 17, 2016
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
78 vials

Product Description

Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016F (01/22/2017), 08092016A (02/05/2017), 09152016E (02/28/2017).