The Recall Desk
SevereFDA (Drugs)·D-0739-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX 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. According to the rubric, an FDA Class II recall involving a sterile compounded drug (where sterility failure implies significant injury risk) falls under the 'Severe' category, as it is not a Class I recall but involves a serious potential hazard.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ. The product is a prescription-only, 5mL glass multiple-dose vial prepared by the pharmacy.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drugs. The affected lot is identified as Lot # t12-12-2016@84 with an expiration date of 5/22/2017.

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 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
1

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 # t12-12-2016@84
  • 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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