Cantrell Drug Recalls Fentanyl Citrate Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride due to a lack of assurance of sterility.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile drug product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Cantrell Drug Company is recalling 471 bags of Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only. The product is identified by NDC 52533-024-35 and Lot 9002.
The recall was initiated because the firm is recalling select sterile drug products due to a lack of assurance of sterility. The affected products were distributed nationwide.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Drug Product
- Affected units
- 471
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 (1)
- Lot: 9002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 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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