Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were 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 for lack of sterility assurance in injectable fentanyl. Sterility failures in injectables pose serious risk of infection; this qualifies as a high-risk product.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling fentanyl citrate injection in 0.9% sodium chloride (10 mcg/mL, 150 mL IV bags, NDC 69374-523-21) due to lack of assurance of sterility. The affected product consists of 3,532 bags from two lot numbers: FN1088A (expiration 6/21/2022) and FN1089A (expiration 6/26/2022).
The product was distributed nationwide in the United States. Lack of sterility assurance in injectable medications carries serious risk of infection from microbial contamination.
Healthcare providers and facilities with the affected product should remove it from use. Patients or providers with questions should contact Nephron Sterile Compounding Center regarding the recall.
The recalled product
- Product
- Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Opioid
- Hazard
- sterility-assurance-failure
- infection-risk
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 (4)
- Lots: FN1088A
- Exp. 6/21/2022
- FN1089A
- Exp. 6/26/2022
Distribution
Distributed nationwide across the United States.
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