Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a compounded injectable pharmaceutical with a manufacturing control failure. Although no illnesses or injuries are reported in the source, the lack of sterility assurance in an injectable opioid product represents a significant risk of harm.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling fentanyl injection, 2500 mcg/50 mL (50 mcg/mL) in 100 mL bags, NDC 71286-2003-4, from Lot 17-275704 with expiration date 10/9/2023. A total of 240 bags were distributed nationwide in the USA.
The product is being recalled due to lack of assurance of sterility, a manufacturing and quality control defect.
Patients and healthcare providers who have received or dispensed this product should discontinue use and contact their healthcare provider or pharmacist to discuss appropriate alternatives.
The recalled product
- Product
- fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Compounded
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:17-275704
- Exp. 10/9/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by Central Admixture Pharmacy Services Inc 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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