The Recall Desk
CriticalFDA (Drugs)·D-1154-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

Cantrell Drug Company is recalling 42 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the criteria for a Critical severity score.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 42 syringes of fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection. The product is distributed in 3 mL syringes and is prescription-only. The specific lot number is 150125, with a date of 12/19/15.

The reason for the recall is that the drug is subpotent, meaning it contains less of the active ingredient than labeled. This recall was initiated by the firm and is classified as Class I by the FDA. The distribution pattern is nationwide.

Patients and healthcare providers should stop using the affected syringes and contact their healthcare provider or pharmacist for guidance. The recall status is currently terminated.

The recalled product

Product
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131
Affected units
42

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: 150125
  • 12/19/15

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 →