The Recall Desk
SevereFDA (Drugs)·D-0744-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable products.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ. The product is a prescription-only sterile compounded drug available in 5 mL glass multiple-dose vials. The recall involves three vials per unit, with specific lot numbers t12-01-2016@93 (expiring 5/22/2017) and t02-02-2017@100 (expiring 8/2/2017).

The recall was initiated because the firm could not ensure the sterility of the compounded drugs within their expiration dates. The affected products were distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected lots immediately. Patients should contact their healthcare provider for further instructions or alternative treatment options.

The recalled product

Product
TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/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
3

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 (4)

  • Lot # t12-01-2016@93
  • Exp 5/22/2017
  • t02-02-2017@100
  • Exp 8/2/2017.

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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