Agency classClass IIOur severity:Severe FDA (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.

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, 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: sterility
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 →

Same manufacturer · Pharm D Solutions, LLC

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