The Recall Desk
SevereFDA (Drugs)·D-0740-2017·Announced 2017-05-24

FDA Recalls Key Pharmacy Compounded Sterile Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to 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 associated with a lack of sterility assurance in an injectable medication.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, a sterile compounded drug prepared by Key Pharmacy and Compounding Center. The product is a prescription-only injection available in 5 mL glass multiple-dose vials.

The recall is being conducted due to a lack of assurance of sterility for the sterile compounded drugs within their expiry date. The specific lot affected is # t01-31-2017@127, with an expiration date of 7/5/2017.

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 pharmacist or healthcare provider for further instructions.

The recalled product

Product
TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Injection
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 # t01-31-2017@127
  • Exp 7/5/2017

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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Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · sterility failure

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