Cantrell Drug Recalls Subpotent Fentanyl Citrate Syringes Nationwide
Cantrell Drug Company is recalling 1,652 syringes of fentanyl citrate because the medication 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 per the rubric mandates a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Cantrell Drug Company is voluntarily recalling 1,652 syringes of fentanyl citrate 50 mcg/mL in sterile water for injection. The affected product is packaged in 2 mL syringes and is labeled for prescription use only. The specific lot number is 6324, with an expiration date of 10/11/15. The product was distributed nationwide.
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 indicates a reasonable probability that use of the product could cause serious adverse health consequences or death. The recall was initiated on August 21, 2015, and was terminated on February 3, 2017.
Healthcare providers and patients should check their inventory for syringes matching the NDC 52533-074-16 and lot number 6324. If found, the product should be returned to Cantrell Drug Company or disposed of according to local regulations. Consumers should not use the recalled product and should contact their healthcare provider for guidance on alternative treatments.
The recalled product
- Product
- fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,652
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: 6324
- exp 10/11/15
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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