The Recall Desk
SevereFDA (Drugs)·D-0979-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Iohexol Injection Due to Sterility Concerns

Fusion IV Pharmaceuticals is recalling Iohexol Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in specific international locations.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Iohexol (PF) Injection, OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by NDC 71283-1413-5, Lot # 10012019+52984, and an expiration date of 1/19/2020. It is a 5 mL single-use vial intended for intrathecal (IA) use and is available by prescription only.

The product was distributed in the U.S.A. nationwide, Puerto Rico, Barbados, and the Dominican Republic. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable
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 (2)

  • Lot #: 10012019+52984
  • Exp 1/19/2020

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 →

Related recalls

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

See all →

Same hazard · sterility

See all →