The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0750-2017·Announced 2017-05-24

FDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.

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. According to the rubric, an FDA Class II recall involving a sterile compounded drug where sterility is not assured is categorized as Severe (Score 4) due to the potential for significant injury or infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, a sterile compounded drug prepared by Key Pharmacy and Compounding Center. The recall is being conducted because the firm lacks assurance of the sterility of the product. The affected product is a prescription-only injection packaged in 5 mL glass multiple-dose vials.

The recall includes 3 vials per lot. The specific lots affected are Lot # t12-02-2016@100 with an expiration date of 5/22/2017, and Lot # t12-28-2016@104 with an expiration date of 6/18/2017. 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 pharmacist or healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/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
3

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 # t12-02-2016@100
  • Exp 5/22/2017
  • t12-28-2016@104
  • Exp 6/18/2017.

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 failure

See all →

Similar recalls