The Recall Desk
SevereFDA (Drugs)·D-0743-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.

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. According to the rubric, an FDA Class II recall involving a sterile compounded drug (where sterility failure implies a risk of serious infection) falls under the 'Severe' category, as it represents a significant risk of harm even without specific hospitalization reports in the text.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific vials of TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ. The product is a prescription-only, sterile compounded drug prepared in 5 mL glass multiple-dose vials. The recall is being conducted because the firm lacks assurance of the sterility of the product.

The affected product is identified by Lot # t11-23-2016@110 and has an expiration date of 5/22/2017. The recall involves 2 vials per unit. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
2

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 # t11-23-2016@110
  • Exp 5/22/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · sterility failure

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