The Recall Desk
SevereFDA (Drugs)·D-1164-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Midazolam Injection Syringes Nationwide

Cantrell Drug Company is recalling 1,570 syringes of Midazolam HCl injection because the drug was found to be subpotent. 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant health risks such as subpotent drugs that may fail to provide the intended therapeutic effect.

Plain-English summary

Cantrell Drug Company, based in Little Rock, Arkansas, is voluntarily recalling 1,570 syringes of MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL). The product is prescription-only and was distributed nationwide. The recall was initiated on August 21, 2015, and was terminated on February 3, 2017.

The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient. The affected lots are 6178 (expiration date 9/12/15) and 6529 (expiration date 11/22/15). The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients who have these specific syringes should stop using them and contact Cantrell Drug Company or their pharmacy for instructions on return or replacement. The recall was initiated by the firm and notified via email.

The recalled product

Product
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161
Manufacturer
Cantrell Drug Company
Category
Drug — Injection
Hazard
Affected units
1,570

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 (5)

  • Lot: 6178
  • exp
  • 9/12/15
  • 6529
  • exp 11/22/15

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 →

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Same hazard · subpotent drug

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