The Recall Desk
SevereFDA (Drugs)·D-0980-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Pyridoxine Hydrochloride Injection Due to Sterility Concerns

Fusion IV Pharmaceuticals is recalling specific lots of Pyridoxine Hydrochloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in several Caribbean territories.

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 agency classification is FDA Class II. Per the rubric, an FDA Class II recall involving a structural or sterility defect in an injectable drug is classified as Severe (Score 4), as it poses a significant risk of adverse health consequences.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Pyridoxine Hydrochloride Injection, 100 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 71283-0216-3. The specific lots subject to the recall are 09132019+52914, 09162019+52920, 09192019+52939, 10292019+53162, and 12112019+53369. These lots have expiration dates ranging from February 28, 2020, to May 27, 2020.

The product was distributed in the United States, Puerto Rico, Barbados, and the Dominican Republic. Healthcare providers and patients should check their inventory and discontinue use of the affected lots. 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
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3
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 (9)

  • Lot #: 09132019+52914
  • Exp 2/28/2020
  • 09162019+52920
  • Exp 3/2/2020
  • 09192019+52939
  • 10292019+53162
  • Exp 4/14/2020
  • 12112019+53369
  • Exp 5/27/2020

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 →