Drug product
TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
D-0311-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35 vials
- Official record key
drug-enforcement:D-0311-2017
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): 05132016A (07/07/2016), 07212016A (09/01/2016), 07292016B (09/08/2016), 08012016F (09/08/2016), 09072016C (09/27/2016), 11012016C (12/09/2016), 05182016E (07/02/2016), 09012016C (09/29/2016), 09272016H (11/06/2016).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility