The Recall Desk
SevereFDA (Drugs)·D-0962-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Lidocaine HCL Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling Lidocaine HCL Injection due to a lack of assurance of sterility. The product is 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Lidocaine HCL (PF) Injection, 4% (PF) 40 mg/mL Injectable, 5 mL Single-use Vial. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by Lot # 07012019+52569 with an expiration date of 3/15/2020. The NDC number is 71283-1011-5. This product is intended for ocular injection and is preservative-free.

The product was distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. Healthcare providers and patients should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5
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 #: 07012019+52569
  • Exp 3/15/2020

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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Same hazard · sterility

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