The Recall Desk
CriticalFDA (Drugs)·D-1157-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

Cantrell Drug Company is recalling 148 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 FDA classified this recall as Class I, which is the highest severity level for drug recalls, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 148 syringes of fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection. The product is a prescription-only medication distributed nationwide. The specific lot number is 150370, with an expiration date of 1/2/16.

The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled. The FDA classified this recall as Class I, which is the most serious classification for drug recalls. The recall was initiated on August 21, 2015, and was terminated on February 3, 2017.

Patients who have used this specific lot of fentanyl citrate injection should contact their healthcare provider for further instructions. The recall was initiated by the firm and notified via email.

The recalled product

Product
fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491
Affected units
148

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: 150370
  • exp 1/2/16

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 →