The Recall Desk
SevereFDA (Drugs)·D-0974-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls MIC-PLEX Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling MIC-PLEX Injection in the U.S., Puerto Rico, Barbados, and the Dominican Republic due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling MIC-PLEX Injection, a vitamin complex intended for intramuscular use. The recall is being conducted because of a lack of assurance of sterility.

The affected product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. The specific lots involved are 11212019+53263 (expiring 2/16/2020) and 11252019+53276 (expiring 2/20/2020).

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions.

The recalled product

Product
MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injection
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 #: 11212019+53263
  • Exp 2/16/2020
  • 11252019+53276
  • Exp 2/20/2020

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

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Same hazard · sterility

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