The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0992-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 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 Cholecalciferol (Vitamin D3) Injection, 1,000 IU/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 71283-0210-3. The specific lots subject to the recall are 04082019+51930 (expiration date 4/8/2020) and 09092019+52891 (expiration date 8/12/2020). The product was distributed in the United States, 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 recalled product

Product
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
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 (4)

  • Lot #: 04082019+51930
  • Exp 4/8/2020
  • 09092019+52891
  • Exp 8/12/2020

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 →

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