The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0967-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Methylcobalamin Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure in an injectable) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Methylcobalamin Injection, 1 mg/mL, 30 mL multi-dose vials. The recall was initiated because the product lacks assurance of sterility. The affected product is a prescription-only injectable intended for intravenous, intramuscular, or subcutaneous use.

The recall includes four specific lot numbers: 07232019+52730 (Exp 1/19/2020), 07232019+52732 (Exp 1/19/2020), 07242019+52748 (Exp 1/20/2020), and 11212019+53272 (Exp 5/19/2020). These products were distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If you have received this product, contact your healthcare provider for guidance on whether to discontinue use or seek alternative treatment. Do not use the recalled product until further notice.

The recalled product

Product
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/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 71283-0331-3
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 (7)

  • Lot #: 07232019+52730
  • Exp 1/19/2020
  • 07232019+52732
  • 07242019+52748
  • Exp 1/20/2020
  • 11212019+53272
  • Exp 5/19/2020

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 failure

See all →

Similar recalls