Drug product
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
D-1576-2019
Product summary
- Firm
- Wise Pharmacy
- Event
- Event 83397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 vials
- Official record key
drug-enforcement:D-1576-2019
Official wording
Reason: Lack of Processing Controls
Code information: Lot #: 6176N, Exp 8/30/2019; 7162N, Exp 10/20/2019
Distribution pattern: CO, TX, WY
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls