FDAClass IINovember 7, 2018

Testosterone in Grapeseed Oil 200 mg/mL recall: Sterility Concern

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

Why was Testosterone in Grapeseed Oil 200 mg/mL recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Pharm D Solutions, LLC
Quantity
a) 4397, b) 4885 c) 1319, d) 4112 vials
Distribution
Nationwide
Recall date
November 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls