The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0950-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Deoxycholic Acid Sodium Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling Deoxycholic Acid Sodium Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in 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. The hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Deoxycholic Acid Sodium Injection, 1.67% Injectable, 30 mL Multi-dose Vial. The recall is being conducted because the product lacks assurance of sterility. The affected product is prescription-only and intended for subcutaneous use.

The recall includes two specific lots: Lot 10082019+53080 (Expiration 6/30/2020) and Lot 11192019+53251 (Expiration 8/24/2020). The NDC for the product is 71283-0462-3. The product was distributed in the United States, Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and consumers should check their inventory for these specific lot numbers and expiration dates. If you have this product, you should stop using it and contact the manufacturer or your healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3
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 (4)

  • Lot #: 10082019+53080
  • Exp 6/30/2020
  • 11192019+53251
  • Exp 8/24/2020

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 →

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