The Recall Desk
SevereFDA (Drugs)·D-0202-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

Pharm D Solutions is recalling 195 vials of Trimix injection nationwide due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is recalling 195 vials of Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product is identified by NDC 69699-1369-02. The recall covers specific lots with discard-by dates ranging from November 1, 2018, to January 1, 2019. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions or a refund.

The recalled product

Product
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
195

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 (5)

  • Lot: 05302018:59 Discard by: 11/26/2018
  • 06132018:44 Discard by: 12/10/2018
  • 06062018:64 Discard by: 12/3/2018
  • 07262018:97 Discard by: 11/1/2018
  • 07052018:23 Discard by: 1/1/2019

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

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Same hazard · sterility

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