The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0200-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns

Pharm D Solutions is recalling 815 vials of Trimix injection because the company cannot guarantee the product is sterile.

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

Plain-English summary

Pharm D Solutions, LLC is voluntarily recalling 815 vials of Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder. The recall is being conducted because the company lacks assurance of the sterility of the affected product.

The affected product is identified by NDC 69699-1366-02. Specific lot numbers and discard dates are listed in the recall documentation, including lots 03292018:70, 05302018:94, 06072018:67, 06122018:72, and 07252018:72. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected vials and contact Pharm D Solutions or their healthcare provider for further instructions.

The recalled product

Product
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Medication
Hazard
Affected units
815

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: 03292018:70 Discard by: 9/25/2018
  • 05302018:94 Discard by: 11/26/2018
  • 06072018:67 Discard by: 12/4/2018
  • 06122018:72 Discard by: 12/9/2018
  • 07252018:72 Discard by: 1/21/2019

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 →

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