The Recall Desk
SevereFDA (Drugs)·D-0940-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls AscorbiX Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection because the product lacks assurance of sterility. The recall covers specific lots 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. Per the rubric, FDA Class II recalls with potential for serious health consequences (such as lack of sterility in injectable products) are categorized as Severe (Score 4), particularly when no explicit 'no illness' statement is provided to lower the score to 3.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling AscorbiX (Buffered C) Injection, a prescription-only injectable product. The recall was initiated because the product lacks assurance of sterility. The affected product is a 30 mL multi-dose vial containing 500 mg/mL of ascorbic acid, intended for intravenous, intramuscular, or subcutaneous use.

The recall includes nine specific lots with expiration dates ranging from February 28, 2020, to June 3, 2020. These lots were distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.

Healthcare providers and patients should stop using the affected lots of AscorbiX Injection. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
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 (18)

  • Lot #: 08222019+52828
  • Exp 2/28/2020
  • 09092019+52889
  • Exp 3/17/2020
  • 09182019+52924
  • Exp 3/26/2020
  • 09262019+52971
  • Exp 4/3/2020
  • 10142019+53108
  • Exp 4/21/2020
  • 10212019+53136
  • Exp 4/28/2020
  • 10302019+53164
  • Exp 5/7/2020
  • 11252019+53278
  • Exp 6/2/2020
  • 11262019+53284
  • Exp 6/3/2020

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 · lack of sterility

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