The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0947-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Coenzyme Q10 Injection Due to Sterility Concerns

Fusion IV Pharmaceuticals is recalling Coenzyme Q10 Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Coenzyme Q10 Injection, 20mg/mL Oil Injection Solution, for IM Use, 10 mL Multi-dose Vial. The recall is being conducted due to a lack of assurance of sterility.

The affected product is prescription-only and was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the recall documentation.

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
Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injection
Hazard

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 (8)

  • Lot #: 06032019+52353
  • Exp 7/29/2020
  • 07082019+52596
  • Exp 9/2/2020
  • 10012019+52986
  • Exp 8/12/2020
  • 12122019+53374
  • Exp 1/25/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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 63 products in this recall →

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Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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