The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0964-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Magnesium Chloride Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection because the company cannot assure the product's sterility.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text explicitly identifies the agency classification as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Magnesium Chloride Injection, 20% Injectable, For IV Use, 50 mL Multi-dose Vial. The recall is being conducted because the company lacks assurance of the product's sterility.

The affected product is identified by NDC 71283-0225-5. The specific lots involved are 10292019+53156 (Expiration 4/26/2020) and 11182019+53247 (Expiration 5/16/2020). These products were distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic.

The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if found.

The recalled product

Product
Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5
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 (4)

  • Lot #: 10292019+53156
  • Exp 4/26/2020
  • 11182019+53247
  • Exp 5/16/2020

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 →

Similar recalls