Pharm D Solutions Recalls Trimix Injection Due to Sterility Concerns
Pharm D Solutions is recalling 430 vials of Trimix injection because the company cannot guarantee the product is 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' rating under the rubric, particularly given the risk of infection from non-sterile injectable medications.
Plain-English summary
Pharm D Solutions, LLC is recalling 430 vials of Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder (NDC 69699-1367-02). The recall was initiated because the company lacks assurance of the product's sterility.
The affected product was distributed nationwide. The recall covers specific lots with discard dates ranging from November 17, 2018, to January 21, 2019. The specific lot numbers and discard dates are: 06132018:87 (Discard by 12/10/2018), 05302018:66 (Discard by 11/25/2018), 06122018:54 (Discard by 11/17/2018), and 07252018:88 (Discard by 1/21/2019).
Consumers and healthcare providers should stop using the affected vials and contact Pharm D Solutions for further instructions or a return.
The recalled product
- Product
- Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 430
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 (4)
- Lot: 06132018:87 Discard by: 12/10/2018
- 05302018:66 Discard by: 11/25/2018
- 06122018:54 Discard by: 11/17/2018
- 07252018:88 Discard by: 1/21/2019
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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