The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0197-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Trimix Injectable because the agency could not ensure the product was 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 involves a lack of assurance of sterility for an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Pharm D Solutions, LLC is recalling 65 milliliters of Trimix Alprostadil/Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable. The recall was initiated due to a lack of assurance of sterility for the affected product.

The affected product is identified by NDC 69699-1330-05. Specific lots involved in the recall include Lot 08062018:52 with a discard by date of 10/5/2018, and Lot 08012018:08 with a discard by date of 9/30/2018. The product was distributed nationwide.

The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should discontinue use of the affected lots and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
65

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 (2)

  • Lot: 08062018:52 Discard by: 10/5/2018
  • 08012018:08 Discard by: 9/30/2018

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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