The Recall Desk
HighFDA (Drugs)·D-0738-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Drug Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile compounded drug with a lack of assurance of sterility, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ. This product is a prescription-only sterile compounded drug injection prepared in 5 mL glass multiple-dose vials. The recall involves six vials per unit.

The recall was initiated due to a lack of assurance of sterility for the sterile compounded drugs within their expiration dates. The affected lots are t11-21-2016@125 (Exp 4/19/2017), t01-09-2017@105 (Exp 6/18/2017), and t01-18-2017@90 (Exp 7/5/2017). These 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 product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/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
6

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 (6)

  • Lot # t11-21-2016@125
  • Exp 4/19/2017
  • t01-09-2017@105
  • Exp 6/18/2017
  • t01-18-2017@90
  • 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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

See all →

Same hazard · sterility

See all →