The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0973-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls MIC-B12 Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling MIC-B12 Injection because the product lacks assurance of sterility. The recall covers multiple lots distributed 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 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 source text identifies the hazard as 'Lack of Assurance of Sterility' for an injectable medication. According to the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are classified as Severe (Score 4). While specific injury reports are not detailed in the provided text, the nature of a sterility failure in an injectable drug presents a significant risk of serious adverse health consequences, aligning with the Severe criteria for Class II recalls with potential for significant harm.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling MIC-B12 Injection, a prescription injectable medication. The recall was initiated because the product lacks assurance of sterility. The affected product is a 30 mL multi-dose vial intended for intramuscular use.

The recall includes specific lots with expiration dates ranging from February 2020 to July 2020. These products were distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Medication
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 (10)

  • Lot #: 07102019+52618
  • Exp 2/8/2020
  • 09052019+52880
  • Exp 4/5/2020
  • 10012019+52983
  • Exp 5/1/2020
  • 11052019+53188
  • Exp 6/5/2020
  • 12112019+53367
  • Exp 7/11/2020

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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Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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