Pharm D Solutions Recalls Trimix ST-1 Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Trimix ST-1 aqueous solution because the company cannot ensure the product is 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, and the hazard involves a lack of assurance of sterility in an injectable pharmaceutical, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharm D Solutions, LLC is voluntarily recalling specific lots of Trimix ST-1 30PA-1.5PH-50A Aqueous Solution. The recall was initiated because the company lacks assurance of the product's sterility.
The affected product is a 40-milliliter aqueous solution distributed nationwide. The recall covers two specific lots: Lot 05312018:12 with a discard by date of 11/27/2018, and Lot 07242018:04 with a discard by date of 1/20/2019.
Consumers and healthcare providers should stop using the affected lots and contact Pharm D Solutions, LLC for further instructions or a replacement.
The recalled product
- Product
- Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Solution
- Affected units
- 40
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: 05312018:12 Discard by: 11/27/2018
- 07242018:04 Discard by: 1/20/2019
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.
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