Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes
Cantrell Drug Company is recalling 884 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 884 syringes of fentanyl citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL. The product is identified by NDC 52533-024-45 and UPC 0100352533024450. The specific lot affected is 6234, with an expiration date of 9/20/15.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient. The recall was initiated by the firm on August 21, 2015, and the FDA classified it as Class I. The affected product was distributed nationwide.
The recall status is currently terminated as of February 3, 2017. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or manufacturer according to the firm's instructions.
The recalled product
- Product
- fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Injection
- Hazard
- Affected units
- 884
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: 6234
- exp 9/20/15
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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