The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0949-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Cyanocobalamin/Folinic Acid Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Cyanocobalamin/Folinic Acid Injection because the product lacks assurance of sterility.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug represents a significant risk of adverse health consequences, aligning with the Severe criteria for Class II drug recalls.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Cyanocobalamin/Folinic Acid Injection, 2000 mcg/mL: 500 mcg/mL, 30 mL multi-dose vials. The recall is due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # 09252019+52967 with an expiration date of 4/4/2020. The product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should stop using the affected product and contact their healthcare provider 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
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
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 (2)

  • Lot #: 09252019+52967
  • Exp 4/4/2020

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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