The Recall Desk
SevereFDA (Drugs)·D-0206-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix Aqueous Solution Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Trimix aqueous solution 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, which corresponds to a Severe severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Trimix ST9D 30PA-2PH-150A Aqueous Solution. The recall was initiated because the company could not provide assurance that the product was sterile. The affected product is a 336-milliliter aqueous solution distributed nationwide.

The recall covers six specific lots with the following discard-by dates: 10/7/2018, 11/6/2018, 11/18/2018, 12/29/2018, 1/14/2019, and 2/4/2019. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be stopped from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Solution
Hazard
Affected units
336

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 (6)

  • Lot: 04102018:12 Discard by: 10/7/2018
  • 05102018:06 Discard by: 11/6/2018
  • 05222018:76 Discard by: 11/18/2018
  • 07022018:35 Discard by: 12/29/2018
  • 08272018:00 Discard by: 1/14/2019
  • 08082018:14 Discard by: 2/4/2019

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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