D-0205-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2018
- Initiation Date
- September 10, 2018
- Termination Date
- February 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343 milliliters
Product Description
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: 04102018:07 Discard by: 10/7/2018; 05102018:18 Discard by: 11/6/2018; 05222018:64 Discard by: 8/1/2018; 07022018:46 Discard by: 12/29/2018; 08012018:81 Discard by: 1/28/2019; 06202018:97 Discard by: 9/17/2018