FentaNYL Citrate IV solution recalled due to sterility assurance concerns
SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.
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: This is an FDA Class II recall involving lack of sterility assurance in an intravenous opioid medication, representing a high-risk contamination scenario. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation consistent with the High severity classification.
Plain-English summary
SterRx, LLC is recalling FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) intravenous bags due to a lack of assurance of sterility. The recalled lot is CHI with an expiration date of December 2022; 720 bags were distributed nationwide in the United States.
Patients and healthcare providers who may have received the affected product should contact SterRx, their dispensing pharmacy, or their healthcare provider for guidance. This is a prescription-only product administered intravenously.
The recalled product
- Product
- FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Intravenous / Opioid
- Hazard
- Affected units
- 720
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 #: CHI
- Exp. Date Dec 22
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SterRx, LLC 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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