The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0199-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Powder Due to Sterility Concerns

Pharm D Solutions is recalling 715 vials of Trimix powder nationwide due to a lack of assurance of sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Pharm D Solutions, LLC is recalling 715 vials of Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder (NDC 69699-1365-10). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was distributed nationwide. The recall includes specific lots with discard dates ranging from September 24, 2018, to January 21, 2019. The source text does not report any illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
715

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: 03292018:02 Discard by: 9/24/2018
  • 05302018:54 Discard by: 11/26/2018
  • 06062018:79 Discard by: 12/3/2018
  • 06122018:31 Discard by: 11/17/2018
  • 07252018:44 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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