The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0213-2019·Announced 2018-11-07

Pharm D Solutions Recalls Testosterone Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II drug recalls with potential for serious harm.

Plain-English summary

Pharm D Solutions, LLC is recalling Testosterone in Grapeseed Oil 200 mg/mL Injectable in 4 mL, 5 mL, 10 mL, and 30 mL vial sizes. The recall is being conducted because the product lacks assurance of sterility. The affected product is identified by NDC 69699-1702-05.

The recall includes specific lots with discard dates ranging from August 30, 2018, to August 22, 2019. The total quantity of affected vials is 4,397 (4 mL), 4,885 (5 mL), 1,319 (10 mL), and 4,112 (30 mL). The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a return. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 79 products in this recall →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

See all →

Same hazard · lack of sterility

See all →

Similar recalls