The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0713-2017·Announced 2017-05-24

Key Pharmacy Recalls CO-Q-10 Oil Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was 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. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug represents a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of CO-Q-10 Oil Injection. The product is a prescription-only, 25mg/mL sterile compounded drug supplied in 20mL glass multiple-dose vials. The recall is being conducted because the firm cannot ensure the sterility of the product within its expiration date.

The affected product is identified by Lot # t02-01-2017@119 and has an expiration date of May 3, 2017. According to the recall notice, this product was distributed nationwide in the United States, as well as in Australia and Canada.

Consumers and healthcare providers should stop using the recalled product immediately. Patients who have already used the product should consult their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
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 # t02-01-2017@119
  • Exp 5/3/2017.

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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