Recalls / Class II
Class IID-0213-2019
Product
Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05
- Affected lot / code info
- Lot: a) Lot: 01302018:77/A Discard by: 1/25/2019; 09042017:74/B Discard by: 8/30/2018; 04042018:51/A Discard by: 3/31/2019; 05152018:94/A Discard by: 5/9/2019; 07022018:04/A Discard by: 6/27/2019; 07162018:80/B Discard by: 7/11/2019; 08272018:15/B Discard by: 8/22/2019; b) 12052017:13/B, Discard by: 11/30/2018; 09042017:74/A Discard by: 8/30/2018; 03212018:39/B Discard by: 3/17/2019; 01302018:77/B Discard by: 1/25/2019; 06262018:25/A Discard by: 6/21/2019; 05212018:45/A Discard by: 5/16/2019; 05152018:94/B Discard by: 5/9/2019; 07162018:80/A Discard by: 7/11/2019 c) Lot: 09132017:58/A Discard by: 9/7/2018; 03212018:39/P Discard by: 3/16/2019; 05012018:45/A Discard by: 4/26/2019; 05012018:45/P Discard by: 4/26/2019; 06042018:58/A Discard by: 5/30/2019; 05152018:94/C Discard by: 5/9/2019; 07022018:04/B Discard by: 6/27/2019 d) Lot: 01082018:40/B Discard by: 1/3/2019; 09042017:74/C Discard by: 8/30/2018; 09132017:58/B Discard by: 9/7/2018; 01302018:77/C Discard by: 1/25/2019; 03212018:39/C Discard by: 3/16/2019; 04042018:51/B Discard by: 3/30/2019; 06042018:58/B Discard by: 5/30/2019; 05012018:45/B Discard by: 4/26/2019; 06132018:02/B Discard by: 6/3/2019; 05212018:94/B Discard by: 5/9/2019; 05152018:94/D Discard by: 5/9/2019; 07162018:80/C Discard by: 7/11/2019; 08062018:67A Discard by: 8/1/2019; 07022018:04/C Discard by: 6/27/2019; 07242018:04/A Discard by: 7/19/2019; 08272018:15/A Discard by: 8/22/2019
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
- a) 4397, b) 4885 c) 1319, d) 4112 vials
- 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-0213-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.