The Recall Desk
SevereFDA (Drugs)·D-0755-2017·Announced 2017-05-24

Key Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix 50/30/1/0.2 injection because the firm cannot assure the sterility of the product.

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 severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ. The product is a prescription-only, 5 mL glass multiple-dose vial prepared by the firm.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling sterile compounded drugs that are within their expiration date because it cannot guarantee that the product is sterile.

The affected product, Lot # t02-02-2017@102 with an expiration date of 7/26/2017, was distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/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
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 # t02-02-2017@102
  • Exp 7/26/2017

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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Same hazard · sterility

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