The Recall Desk
SevereFDA (Drugs)·D-1161-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Lidocaine HCl Injection Syringes

Cantrell Drug Company is recalling 450 syringes of Lidocaine HCl 1% injection due to subpotent drug levels. The recall is voluntary and nationwide.

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 source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly when no specific hospitalization reports are detailed but the classification is elevated.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 450 syringes of Lidocaine HCl 1% Buffered with Sodium Bicarbonate Injection. The product is packaged in 3 mL syringes and is available by prescription only. The recall covers two specific lots: 150947 (expiration date 9/5/15) and 151087 (expiration date 9/21/15).

The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient required. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide. The recall was initiated on August 21, 2015, and was terminated on February 3, 2017. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If found, the product should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033
Manufacturer
Cantrell Drug Company
Category
Drug — Injection
Hazard
Affected units
450

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: 150947
  • exp 9/5/15
  • 151087
  • exp 9/21/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Cantrell Drug Company 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 13 products in this recall →

Related recalls

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Same hazard · subpotent drug

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