Fentanyl Citrate Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
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 with no reported illnesses or injuries. Although lack of sterility in injectable medications poses a significant contamination risk, the absence of reported harm classifies this as a risk-of-harm situation without documented injury, supporting a Score 3.
Plain-English summary
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL in sterile water (NDC 71139-6030-1) from lot 20231020FEN-1, which expired April 17, 2024. The recall is due to a lack of assurance of sterility caused by leaking bags discovered in the affected lot.
Leaking bags compromise the sterile integrity of injectable medications. Fentanyl citrate is a high-potency opioid administered via CADD (Continuous Ambulatory Drug Delivery) pumps directly into the bloodstream, making sterility assurance critical to prevent contamination and infection.
This product was distributed nationwide within the United States. Healthcare facilities, pharmacies, and patients with cassettes from lot 20231020FEN-1 should discontinue use immediately and not administer any product from this lot.
Patients and healthcare providers should contact IntegraDose Compounding Services LLC at 719 Kasota Ave SE, Minneapolis, Minnesota, for instructions on returning unused cassettes from the affected lot.
The recalled product
- Product
- fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
- injection-contamination
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#: 20231020FEN-1
- Exp: 04/17/2024
Distribution
Distributed nationwide across the United States.
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