The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0975-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls MIC-PLUS Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling MIC-PLUS Injection, a vitamin complex, due to a lack of assurance of sterility. The 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly given the risk associated with non-sterile injectable medications.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE. The recall is being conducted due to a lack of assurance of sterility in the product. The affected product is a 30 mL multi-dose vial intended for intramuscular use and is available by prescription only.

The recall covers specific lots with expiration dates ranging from January 2020 to June 2020. The product was distributed in the United States, Puerto Rico, Barbados, and the Dominican Republic. 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 or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots of MIC-PLUS Injection. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.

The recalled product

Product
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/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 71283-0231-3
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Vitamin
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 (11)

  • Lot #: 06242019+52513
  • Exp 1/23/2020
  • 06242019+52515
  • 07252019+52756
  • Exp 2/23/2020
  • 08212019+52823
  • Exp 3/21/2020
  • 10012019+52989
  • Exp 5/1/2020
  • 11062019+53194
  • Exp 6/6/2020

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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