The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0751-2017·Announced 2017-05-24

Key Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in sterile injections are categorized as Severe.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ. The product is a prescription-only, sterile compounded drug supplied in 5 mL glass multiple-dose vials. The recall involves four vials per unit.

The recall was initiated due to a lack of assurance of sterility for the compounded drugs within their expiry dates. The affected lots are identified as t12-12-2016@93 (expiring 5/22/2017) and t02-22-2017@93 (expiring 8/2/2017).

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 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/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
4

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 # t12-12-2016@93
  • Exp 5/22/2017
  • t02-22-2017@93
  • 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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