The Recall Desk
SevereFDA (Drugs)·D-0735-2017·Announced 2017-05-24

Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ 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, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable drugs are categorized as Severe (Score 4), particularly when structural or significant injury risks are implied by the lack of sterility in a parenteral product.

Plain-English summary

Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, a prescription-only sterile compounded drug. The product is available in 5 mL glass multiple-dose vials, with 2 vials per package. The specific lot affected is # t12-22-2016@102, with an expiration date of 6/18/2017.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drugs within their expiration date. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be discontinued from use and returned to the pharmacy or supplier in accordance with standard recall procedures.

The recalled product

Product
TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/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 # t12-22-2016@102
  • Exp 6/18/2017

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 →

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