The Recall Desk
SevereFDA (Drugs)·D-0191-2019·Announced 2018-11-07

Pharm D Solutions Recalls Tri-Mix Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

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 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 609 vials of Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg Injectable and Powder. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product includes specific lots with discard dates ranging from October 2018 to March 2019. The recall number is D-0191-2019, and the agency classification is Class II. 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
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
609

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: a) 09062018:87 Discard by: 1/14/2019 b) 04042018:44 Discard by: 10/29/2018
  • 09022018:04 Discard by: 3/1/2019
  • 05212018:44 Discard by: 11/17/2018
  • 06122018:83 Discard by: 12/9/2018
  • 08132018:86 Discard by: 2/9/2019

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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Same hazard · sterility

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