D-0213-2019 Class II Terminated

Recalled by Pharm D Solutions, LLC — Houston, TX

FDA drug recall D-0213-2019 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: a) 4397, b) 4885 c) 1319, d) 4112 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
a) 4397, b) 4885 c) 1319, d) 4112 vials

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0213-2019
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.