Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0213-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 10, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- a) 4397, b) 4885 c) 1319, d) 4112 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0213-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81002
- Address
- 1304 S Loop W
- Code information
- 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
- Postal code
- 77054-4010
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0213-2019
- Classification
- Class II
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- a) 4397, b) 4885 c) 1319, d) 4112 vials
- Termination date
- Feb 5, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 10, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 1, 2018