Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Trimix Injectable 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 and involves a lack of assurance of sterility for an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharm D Solutions, LLC is recalling 65 milliliters of Trimix Alprostadil/Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable. The recall was initiated due to a lack of assurance of sterility for the affected product.
The affected product is identified by NDC 69699-1330-05. Specific lots involved in the recall include Lot 08062018:52 with a discard by date of 10/5/2018, and Lot 08012018:08 with a discard by date of 9/30/2018. The product was distributed nationwide.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should discontinue use of the affected lots and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Affected units
- 65
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: 08062018:52 Discard by: 10/5/2018
- 08012018:08 Discard by: 9/30/2018
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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