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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable
- Hazard
- 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.
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