Drug product
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
D-1575-2019
Product summary
- Firm
- Wise Pharmacy
- Event
- Event 83397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 vials
- Official record key
drug-enforcement:D-1575-2019
Official wording
Reason: Lack of Processing Controls
Code information: Lot #: 5620N, Exp 7/16/2019; 6221N, Exp 8/31/2019; 6952N, Exp 10/16/2019
Distribution pattern: CO, TX, WY
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls