The Recall Desk
SevereFDA (Drugs)·D-1162-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Midazolam HCl Injection Syringes

Cantrell Drug Company is recalling 3,853 syringes of Midazolam HCl injection because the drug was 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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall must be assigned a score of at least 4 (Severe), regardless of whether specific injuries are reported in the text.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 3,853 syringes of Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL, 1 mL. The recall was initiated because the product was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient.

The affected product is identified by NDC 52533-157-45 and UPC 0100352533157455. The recall covers two specific lots: Lot 6218 with an expiration date of 9/17/15, and Lot 6877 with an expiration date of 1/24/16. The product was distributed nationwide.

This is an FDA Class II recall, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The recall was initiated by the firm and is currently terminated.

The recalled product

Product
Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455
Manufacturer
Cantrell Drug Company
Category
Drug — Injection
Hazard
Affected units
3,853

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: 6218
  • exp 9/17/15
  • 6877
  • exp 1/24/16

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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