The Recall Desk
SevereFDA (Drugs)·D-0193-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable because the agency could not ensure the product was sterile.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe.

Plain-English summary

Pharm D Solutions, LLC is recalling Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, 20 milliliters, NDC 69699-1354-03. The recall was initiated due to a lack of assurance of sterility for the product.

The affected product is identified by Lot 07262018:58 with a discard by date of 1/21/2019. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide. Consumers and healthcare providers should stop using the affected lot and contact Pharm D Solutions or their healthcare provider for further instructions.

The recalled product

Product
Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
20

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 (1)

  • Lot: 07262018:58 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 →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

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Same hazard · sterility

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