Drug product
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy.
D-0251-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 vials
- Official record key
drug-enforcement:D-0251-2017
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): 06092016B (0724/2016), 07212016C (09/04/2016), 09162016A (10/31/2016), 11012016A (12/16/2016).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility