The Recall Desk
SevereFDA (Drugs)·D-0014-2017·Announced 2016-10-19

FDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns

Leiter's Compounding is recalling Lidocaine HCl and Phenylephrine HCl injection vials because they were produced using recalled filters, raising concerns about 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. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (such as loss of sterility in an injectable drug) is categorized as Severe (Score 4), particularly when it involves a risk of serious injury or hospitalization potential, even if specific hospitalization reports are not explicitly detailed in the short source text, the 'Lack of Assurance of Sterility' for an injection is a significant hazard.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection, compounded by Leiter's Compounding in San Jose, CA. The recall involves 76,315 units of the product, which is distributed nationwide. The specific NDC for the affected product is 70360-002-35.

The reason for the recall is a lack of assurance of sterility. The FDA notes that all compounded products within their expiration dates were produced using filters that have themselves been recalled. The affected lots have expiration dates ranging from 10/03/2016 to 12/19/2016.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
Manufacturer
Leiter's Compounding
Category
Drug — Injectable
Hazard
Affected units
76,315

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)

  • All unexpired lots
  • Expirations dates of 10/03/2016 to 12/19/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Leiter's Compounding 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 9 products in this recall →

Related recalls

Same manufacturer · Leiter's Compounding

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Same hazard · sterility

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