Pharm D Solutions Recalls Trimix ST-9B Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Trimix ST-9B aqueous solution because the company cannot guarantee the product's sterility.
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 rating under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Pharm D Solutions, LLC is recalling specific lots of Trimix ST-9B 30 PA-2PH-100A Aqueous Solution. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is identified by NDC 69699-1344-05 and is packaged in 59-milliliter quantities. The recall covers three specific lots with the following discard-by dates: Lot 04262018:54 (discard by 10/23/2018), Lot 03292018:91 (discard by 9/24/2018), and Lot 05312018:10 (discard by 11/27/2018). The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot numbers and discard-by dates. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for disposal or credit in accordance with standard recall procedures.
The recalled product
- Product
- Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 59
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 (3)
- Lot: 04262018:54 Discard by: 10/23/2018
- 03292018:91 Discard by: 9/24/2018
- 05312018:10 Discard by: 11/27/2018
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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