D-0144-2019 Class II Terminated
FDA drug recall D-0144-2019 was initiated by Pharm D Solutions, LLC on Sep 10, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Feb 5, 2021). Affected quantity: 29 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 7, 2018
- Initiation Date
- Sep 10, 2018
- Termination Date
- Feb 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 vials
Product Description
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lots: a)04032018:49 Discard by: 9/30/2018; 05242018:72 Discard by: 11/20/2018; b) 06192018:08 Discard by: 12/16/2018; 06132018:29 Discard by: 12/10/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0144-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026