Fentanyl Citrate IV Bags Recalled Due to Sterility Assurance Failure
SterRx is recalling 360 bags of fentanyl citrate IV medication due to lack of assurance of sterility. No illnesses have been reported.
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: This is a risk-of-harm product (sterile IV medication) where lack of sterility assurance poses potential infection risk. The source reports no illnesses, making the hazard theoretical per FDA Class II standards, warranting High severity.
Plain-English summary
SterRx, LLC is recalling fentanyl citrate in 0.9% sodium chloride IV bags (2.5 mg per 250 mL, 10 mcg per mL) due to lack of assurance of sterility. The recalled product consists of 360 bags with lot number CHL and expiration date December 29, 2022, distributed nationwide in the United States. The product NDC is 70324-327-02 and is manufactured by SterRx, LLC, located at 141 Idaho Avenue, Plattsburgh, NY 12903.
The recall is due to inadequate assurance that the product meets sterility requirements, which could pose a risk to patients receiving the medication through intravenous injection. Sterile injectable products must meet strict sterility standards to prevent potential infections.
Healthcare providers and patients should stop using the recalled product immediately if they have units from lot CHL with expiration date December 29, 2022. Patients who have received doses from this lot should contact their healthcare provider for guidance.
The recalled product
- Product
- fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Sterile Injectable
- Hazard
- sterility-assurance-failure
- contamination-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 (3)
- Lot #: CHL
- Exp. Date Dec 29
- 2022
Distribution
Distributed nationwide across the United States.
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