Recalls / Class II
Class IID-0175-2019
Product
Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05
- Affected lot / code info
- Lot: 04252018:84 Discard by: 10/22/2018; 03292018:62 Discard by: 9/24/2018; 05312018:52 Discard by: 11/27/2018; 07022018:82 Discard by: 11/17/2018; 06122018:96 Discard by: 12/9/2018; 07242018:22 Discard by: 1/20/2019; 08302018:71 Discard by: 2/23/2019
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
- 189 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-0175-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.