Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Trimix QM10 Injectable 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable drug.
Plain-English summary
Pharm D Solutions, LLC is recalling 9 vials of Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected product is identified by NDC 69699-1352-05. The specific lots subject to the recall are 04262018:09 (Discard by 10/22/2018) and 07022018:48 (Discard by 12/29/2018). The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact Pharm D Solutions, LLC or their healthcare provider for further instructions.
The recalled product
- Product
- Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 9
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: 04262018:09 Discard by: 10/22/2018
- 07022018:48 Discard by: 12/29/2018
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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