Drug product
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
D-0308-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 78 vials
- Official record key
drug-enforcement:D-0308-2017
Official wording
Reason: Lack of Assurance of Sterility
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).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility