Recalls / Class II
Class IID-1573-2019
Product
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Affected lot / code info
- Lot #: 6054N; 4796N, Exp 7/16/2019; 7049N, Exp 11/24/2019
Why it was recalled
Lack of Processing Controls
Recalling firm
- Firm
- Wise Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6179 S Balsam Way Ste 150, N/A, Littleton, Colorado 80123-3095
Distribution
- Quantity
- 84 vials
- Distribution pattern
- CO, TX, WY
Timeline
- Recall initiated
- 2019-07-22
- FDA classified
- 2019-07-31
- Posted by FDA
- 2019-08-07
- Terminated
- 2020-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1573-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.