D-0191-2019 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
- 609 vials
Product Description
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: a) 09062018:87 Discard by: 1/14/2019 b) 04042018:44 Discard by: 10/29/2018; 09022018:04 Discard by: 3/1/2019; 05212018:44 Discard by: 11/17/2018; 06122018:83 Discard by: 12/9/2018; 08132018:86 Discard by: 2/9/2019