The Recall Desk
SevereFDA (Drugs)·D-0977-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection because the FDA determined there is a lack of assurance of 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or those that meet the criteria for Severe (score 4), are assigned this level. While the specific injury reports are not detailed in the snippet, the agency classification of Class II for a sterile injectable product aligns with the 'Severe' criteria in the absence of Class I indicators.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection, 50 mg/mL, 10 mL single-use vials. The recall was initiated due to a lack of assurance of sterility in the product.

The affected product is an injectable medication intended for intravenous (IV) or intramuscular (IM) use. The recall covers lots 08282019+52850 (expiring 1/24/2020), 10102019+53094 (expiring 2/28/2020), and 10312019+53174 (expiring 3/28/2020). The product was distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should discontinue use of the affected lots and contact the manufacturer or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1
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 (6)

  • Lot #: 08282019+52850
  • Exp 1/24/2020
  • 10102019+53094
  • Exp 2/28/2020
  • 10312019+53174
  • Exp 3/28/2020

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 failure

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