SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves lack of sterility assurance in an injectable pharmaceutical product, which presents a significant risk of harm to patients receiving the medication, even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
SterRx, LLC is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection, 1 mg per 100 mL (10 mcg per mL), due to lack of assurance of sterility.
The recall affects approximately 10,660 bags distributed nationwide in the United States. The affected product was manufactured under lot codes S21349/CAI (23-Mar-22), S21356/CAP (1-Apr-22), and S21361/CAU (2-Apr-22), with NDC 70324-327-01.
Fentanyl citrate is a prescription opioid medication administered by injection. A failure to assure sterility in injectable medications poses a potential risk to patients who receive the product.
Consumers and healthcare providers who have received this product should contact SterRx, LLC or consult their healthcare provider for guidance on next steps.
The recalled product
- Product
- Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 10,660
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 (1)
- S21349/CAI 23-Mar-22 S21356/CAP 1-Apr-22 S21361/CAU 2-Apr-22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 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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