The Recall Desk
ModerateFDA (Drugs)·D-1163-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Midazolam Syringes Nationwide

Cantrell Drug Company is recalling 212 syringes of Midazolam HCl that may contain less than the labeled amount of active ingredient.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is subpotency (low-risk contamination/efficacy issue) without reported injuries, fitting the Moderate criteria.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 212 syringes of MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE, 2.5 mL. The recall was initiated because the product was found to be subpotent, meaning it may contain less than the labeled amount of the active drug ingredient.

The affected product is identified by Lot 149167 with an expiration date of 9/2/15. The syringes were distributed nationwide. The recall was initiated on August 21, 2015, and was terminated on February 3, 2017.

Patients and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for credit. Patients who have already used the product should contact their healthcare provider if they have concerns about their treatment.

The recalled product

Product
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Affected units
212

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: 149167
  • exp 9/2/15

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 →