The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0192-2019·Announced 2018-11-07

Pharm D Solutions Recalls Trimix BM3 Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable because the agency could not ensure the product was 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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a structural or sterility defect in an injectable drug is classified as Severe (Score 4), as it poses a significant risk of adverse health consequences.

Plain-English summary

Pharm D Solutions, LLC is recalling Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable (NDC 69699-1310-03) due to a lack of assurance of sterility. The affected product is a 67-milliliter injectable solution distributed nationwide.

The recall involves specific lots with the following discard-by dates: Lot 05072018:35 (discard by 11/3/2018) and Lot 06122018:01 (discard by 12/9/2018). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
67

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: 05072018:35 Discard by: 11/3/2018
  • 06122018:01 Discard by: 12/9/2018

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.

See all 79 products in this recall →

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