The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1339-2019·Announced 2019-06-19

Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Trimix injectable vials due to a lack of sterility assurance.

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 and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is recalling 4 vials of Trimix 30mg/1 mg/10mcg/mL Injectable. The product is a prescription-only medication containing 30 mg Papaverine, 1 mg phentolamine mesylate, and 30 mcg alprostadil. The recall is being conducted because of a lack of sterility assurance.

The affected product is identified by Lot # 05022019:90 with an expiration date of 07/13/2019. The recall covers distribution nationwide within the United States.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions at 1-844-263-6846 for further instructions.

The recalled product

Product
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
4

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 (1)

  • Lot #: 05022019:90 Exp. 07/13/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 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.

See all 18 products in this recall →

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