Recalls / Class II
Class IID-0205-2019
Product
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 343 milliliters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0205-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.