Drug product
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
D-0248-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 201 vials
- Official record key
drug-enforcement:D-0248-2017
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): 07192016WW (01/15/2017), 07152016G (01/11/2017), 08292016A (02/25/2017), 10262016B (02/28/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility