The Recall Desk
SevereFDA (Drugs)·D-0941-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls B-Complex 110 Injectable Due to Sterility Concerns

Axia Pharmaceutical is recalling B-Complex 110 Injectable vials due to a lack of assurance of sterility. The affected lots were distributed nationwide and in several international locations.

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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of B-Complex 110 Injectable. The product is a 30 mL multi-dose vial intended for intravenous, intramuscular, or subcutaneous use and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.

The affected product includes NDC 71283-0212-3. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in March, April, and August 2020. The product was distributed in the United States, Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should stop using the affected lots of B-Complex 110 Injectable. Consumers should consult their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product
B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
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 (8)

  • Lot #: 07022019+52584
  • 07022019+52579
  • Exp 3/29/2020
  • 08012019+52780
  • 08012019+52782
  • Exp 4/28/2020
  • 11262019+53288
  • Exp 8/23/2020

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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