The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0736-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated as Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in a sterile compounded drug presents a significant risk profile consistent with this classification level.

Plain-English summary

Key Pharmacy and Compounding Center is recalling the sterile compounded drug TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ. The product is a prescription-only injection containing 10mcg/15mg/2.5mg/mL in a 5 mL glass multiple-dose vial.

The recall is being conducted because the firm lacks assurance of the sterility of the product. The affected lot is identified as Lot # t12-19-2016@69 with an expiration date of 5/22/2017.

The product was distributed nationwide in the U.S.A., Australia, and Canada. Patients who have received this medication should consult their healthcare provider regarding the recall and potential risks associated with the lack of sterility assurance.

The recalled product

Product
TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/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
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 # t12-19-2016@69
  • Exp 5/22/2017

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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