The Recall Desk
SevereFDA (Drugs)·D-0961-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.

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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Levocarnitine Injection, 500 mg/mL, 30 mL multi-dose vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.

The affected product is identified by NDC 71283-9260-3 and Lot # 08212019+52824, with an expiration date of 2/17/2020. The product was distributed nationwide in the United States, as well as in 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
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
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 (2)

  • Lot #: 08212019+52824
  • Exp 2/17/2020

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

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Same hazard · sterility

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