Drug product
Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
D-0270-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 987 vials
- Official record key
drug-enforcement:D-0270-2017
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): 09022016A (12/31/2016), 07282016C (12/31/2016)
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility