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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injection
- Hazard
- 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.
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