FDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns
Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 for a sterile injectable drug with lack of sterility assurance. Although no illnesses or injuries have been reported, the hazard is high-risk and affects patient safety if the product was contaminated and administered.
Plain-English summary
Fagron Compounding Services is recalling fentanyl Citrate in Sodium Chloride 1600mcg/100mL IV bags. The recall affects 1,330 units of Lot #C274-000040409 (expiration date March 2025) distributed in Pennsylvania.
The recall is due to lack of assurance of sterility. As a compounded injectable medication, the product must meet strict sterility standards to prevent contamination and potential patient harm.
Healthcare facilities that received these bags should discontinue use immediately and verify whether the affected product was administered to any patients. Any patients who received medication from this product should contact their healthcare provider for evaluation and monitoring.
The recalled product
- Product
- fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Injectable Medication
- Affected units
- 1,330
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 # C274-000040409
- Exp 03/22/2025
Distribution
Distributed in 1 state:
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