The Recall Desk
SevereFDA (Drugs)·D-0745-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Drug Vials Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 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 drugs.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 17 vials of TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ. This prescription-only sterile compounded drug is distributed in 5 mL glass multiple-dose vials. The recall covers specific lots with expiration dates ranging from May 22, 2017, to August 2, 2017.

The recall was initiated due to a lack of assurance of sterility for the sterile compounded drugs. 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 vials immediately and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/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
17

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 (12)

  • Lot # t12-07-2016@97
  • Exp 5/22/2017
  • t12-12-2016@88
  • t12-20-2016@109
  • t12-20-2016@119
  • Exp 6/18/2017
  • t12-23-2016@63
  • t12-30-2016@84
  • t01-09-2017@97
  • t12-22-2016@120
  • t02-07-2017@72
  • 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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

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Same hazard · lack of sterility

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