The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0737-2017·Announced 2017-05-24

Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the hazard involves sterility assurance which carries significant risk of infection.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ. The product is a prescription-only, 5 mL glass multiple-dose vial containing 10mcg/30mg/0.5mg/mL. The recall is being conducted due to a lack of assurance of sterility in the compounded drugs.

The affected lots were distributed nationwide in the U.S.A., Australia, and Canada. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from November 2016 to February 2017. The source text does not report any illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/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
200

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 (13)

  • Lot # 11-18-2016@70
  • Exp 4/19/2017
  • 11-23-2016@84
  • Exp 5/22/2017
  • t12-14-2016@99
  • t01-03-2017@94
  • Exp 6/18/2017
  • 01-13-2017@71
  • Exp 7/5/2017
  • 01-25-2017@103
  • 02-06-2017@94
  • t02-17-2017@87
  • 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

See all →

Same hazard · sterility

See all →

Similar recalls