The Recall Desk
HighFDA (Drugs)·D-0190-2019·Announced 2018-11-07

Pharm D Solutions Recalls Tri-Mix XL Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 553 vials of Tri-Mix XL injectable and powder nationwide due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile injectable drug with a lack of assurance of sterility, which poses a risk of harm (infection) even though no specific illnesses are reported in the source text.

Plain-English summary

Pharm D Solutions, LLC is recalling 553 vials of Tri-Mix XL 150 mg/10 mg/100 mcg, available as an injectable and a lyophilized powder. The product is distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.

The affected lots include specific injectable and powder batches with discard dates ranging from September 24, 2018, to February 9, 2019. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.

The recalled product

Product
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
553

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 (6)

  • Lot: a) 04132018:97 Discard by: 10/10/2018
  • 04032018:25 Discard by: 9/30/2018
  • b) 04162018:29 Discard by: 10/11/2018
  • 03282018:80 Discard by: 9/24/2018
  • 06122018:06 Discard by: 12/9/2018
  • 08132018:55 Discard by: 2/9/2019

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.

See all 79 products in this recall →

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