The Recall Desk
SevereFDA (Drugs)·D-0945-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Biotin Injectable Suspension Due to Sterility Concerns

Axia Pharmaceutical is recalling Biotin Injectable Suspension due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' in an injectable product presents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Axia Pharmaceutical, doing business as Fusion IV Pharmaceuticals, Inc., is recalling Biotin (Vitamin H) Injectable Suspension, 10 mg/mL, 30 mL multi-dose vials. The recall is being conducted due to a lack of assurance of sterility in the product.

The affected product is identified by Lot # 11132019+53229 with an expiration date of 2/10/2020. The product was distributed nationwide in the United States, 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
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
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 #: 11132019+53229
  • Exp 2/10/2020

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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