Cantrell Drug Company Recalls Fentanyl Citrate Bags Due to Sterility Concerns
Cantrell Drug Company is recalling Fentanyl Citrate bags due to a lack of assurance of sterility. The recall affects 2,545 bags distributed nationwide.
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 recall is classified as FDA Class II and involves a sterile drug product with a lack of assurance of sterility, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Cantrell Drug Company is recalling Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL single-dose bags. The recall is being conducted because the firm lacks assurance of the sterility of the affected drug products.
The recall involves 2,545 bags from Lot 8990. These products were distributed nationwide. The affected product is identified by NDC 52533-024-61.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 2,545
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: 8990
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.
See all 21 products in this recall →Related recalls
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