The Recall Desk
SevereFDA (Drugs)·D-1155-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

Cantrell Drug Company is recalling 235 syringes of fentanyl citrate 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 FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.

Plain-English summary

Cantrell Drug Company is voluntarily recalling 235 syringes of fentanyl citrate 25 mcg/mL in 5% dextrose injection. The product is identified by Lot 151142 and an expiration date of 10/22/15. The recall was initiated because the drug was found to be subpotent, meaning it contained less of the active ingredient than labeled.

The affected product was distributed nationwide. The recall was initiated on August 21, 2015, and the FDA classified it as Class I. The recall status is currently terminated as of February 3, 2017.

Healthcare providers and patients should stop using the affected syringes and contact Cantrell Drug Company or their supplier for instructions on return or replacement. The FDA has not reported specific illnesses or injuries associated with this recall in the provided text.

The recalled product

Product
fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301
Affected units
235

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: 151142
  • exp 10/22/15

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 →