The Recall Desk
SevereFDA (Drugs)·D-0952-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Dexpanthenol Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The affected lots were distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Dexpanthenol Injection, 250 mg/mL, 30 mL multi-dose vials. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by NDC 71283-0214-3. The specific lots subject to the recall are 07242019+52740 (expiration date 1/20/2020) and 11202019+53259 (expiration date 5/18/2020). The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should stop using the affected lots of Dexpanthenol Injection. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions regarding the recalled product.

The recalled product

Product
Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Medication
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 #: 07242019+52740
  • Exp 1/20/2020
  • 11202019+53259
  • Exp 5/18/2020

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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