Drug product
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
D-1574-2019
Product summary
- Firm
- Wise Pharmacy
- Event
- Event 83397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 vials
- Official record key
drug-enforcement:D-1574-2019
Official wording
Reason: Lack of Processing Controls
Code information: Lot #: 5333N, Exp 7/12/2019; 7000N, Exp 10/18/2019
Distribution pattern: CO, TX, WY
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls